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Research question: To determine whether the use of oral dydrogesterone (DYD) in luteal phase support (LPS) during an artificial cycle provides equivalent clinical and ongoing pregnancy, delivery and miscarriage rates as micronized vaginal progesterone (MVP) in oocyte donation recipients. Design: This was a retrospective observational study of prospectively collected data from the assisted reproductive technology (ART) Department of Lille University Hospital from July 2018 to July 2022. All recipients underwent endometrial preparation by an artificial cycle. Luteal phase support (LPS) was provided by weekly intramuscular progesterone (IM) (500 mg/2 ml) and either DYD (40 mg/day) or MVP (800 mg/day) for 12 weeks if the pregnancy test was positive. The primary endpoint was the clinical pregnancy rate. Results: Our study analysed 372 oocyte donation cycles with embryo transfer: 162 embryo transfers with DYD + IM progesterone and 210 embryo transfers with MVP + IM progesterone. After adjustment for confounding factors, our two groups were comparable in terms of clinical pregnancy rates, with 36.7% in the MVP group versus 30.3% in the DYD group (p = 0.55); ongoing pregnancy rates (29,1% versus 25.3%, p = 0.95); miscarriage rates (7.6% versus 4.9%, p = 0.35); and live birth rates (26.7% versus 25.3%, p = 0.86). Conclusion: Oral dydrogesterone seems to be a good alternative to vaginal micronized progesterone for LPS treatment during an artificial cycle, especially in combination with a weekly injection of intramuscular progesterone in the course of oocyte donation. [ABSTRACT FROM AUTHOR]

Objective: To determine the effectiveness of oral dydrogesterone in preventing miscarriage in threatened miscarriage. Methods: A randomized, controlled trial study was conducted among pregnant Thai women at the gestational age of six to less than 20 weeks who visited King Chulalongkorn Memorial Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand with threatened miscarriage from August 2021 to August 2022. These pregnant women were randomized to receive oral dydrogesterone 20 mg per day or placebo twice a day until one week after vaginal bleeding stopped or otherwise for a maximum of six weeks. Results: A total of 100 pregnancies were recruited. Fifty of them were assigned to receive oral dydrogesterone and 50 were assigned to receive placebo. The rate of continuing pregnancy beyond 20 weeks of gestational age was 90.0% (45 out of 50 women) in the dydrogesterone group and 86.0% (43 out of 50 women) in the placebo group (p = 0.538). The incidence of adverse events did not differ significantly between the groups. Conclusion: Oral dydrogesterone 20 mg/day could not prevent miscarriages in women with threatened miscarriage. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusionOral, low-dose and ultra-low-dose continuous combined 17β-estradiol (E) plus dydrogesterone (D) reduce vasomotor symptoms (VMS) in postmenopausal women.Two phase 3, double-blind studies were included. In the European study, postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg (ultra-low dose), E1 mg/D5 mg (low dose) or placebo for 13 weeks. In the Chinese study, women were randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks. Post-hoc endpoints assessed in body mass index (BMI) subgroups (<25 kg/m2; ≥25 kg/m2) included number of hot flushes and moderate-to-severe hot flushes per day, and the proportion of women with amenorrhea.A total of 640 women were included. At the end of treatment, the mean (95% confidence interval) numbers of daily hot flushes were significantly lower (p ≤ 0.05) for all treatment groups versus placebo, with E0.5 mg/D2.5 mg (BMI < 25 kg/m2: 2.5 [1.9, 3.1]; BMI ≥ 25 kg/m2: 3.2 [2.5, 3.8]) and E1 mg/D5 mg versus placebo (BMI < 25 kg/m2: 2.7 [1.2, 4.2]; BMI ≥ 25 kg/m2: 2.3 [1.1, 3.5]) than with placebo (BMI < 25 kg/m2: 4.4 [3.8, 50]; BMI ≥ 25 kg/m2: 4.2 [3.6, 4.9]). A similar pattern was seen for moderate-to-severe hot flushes. The amenorrhea rate was high (79–98%) across both studies and BMI subgroups.Oral, ultra-low-dose continuous combined E0.5 mg/D2.5 mg and low-dose continuous combined E1 mg/D5 mg alleviated postmenopausal VMS compared with placebo, irrespective of BMI. [ABSTRACT FROM AUTHOR]

Background/Aims: Threatened miscarriage, marked by vaginal bleeding during the first 20 weeks of pregnancy, is a frequent complication with potential adverse outcomes. Dydrogesterone and micronized progesterone are commonly prescribed to manage this condition, yet their comparative efficacy remains under debate. This study aims to evaluate the effectiveness and safety of dydrogesterone versus micronized progesterone in treating threatened miscarriage. Methods: A retrospective case-control study was conducted at Our Hospital, including 123 pregnant women aged 6 to 20 weeks presenting with uterine bleeding. Participants were divided into two groups based on receiving either dydrogesterone (n=56) or micronized progesterone (n=67). Pregnancy outcomes, including miscarriage rates, preterm labor, and mode of delivery, were recorded and analyzed using SPSS software. Results: The miscarriage rate was slightly higher in the dydrogesterone group (9.6%) compared to the progesterone group (5.9%), though this difference was not statistically significant (p=0.729). Both groups exhibited high rates of successful delivery, with no significant difference between them (p>0.05). Additionally, no significant differences were observed in the incidence of pregnancy complications or mode of delivery between the two groups. Conclusion: Both dydrogesterone and micronized progesterone are effective in managing threatened miscarriage, with no significant differences in pregnancy outcomes. Further largescale, randomized trials are needed to confirm these findings and refine treatment guidelines. [ABSTRACT FROM AUTHOR]

Objective: Among postmenopausal women, oral, ultra-low-dose continuous combined estradiol (E0.5 mg) plus dydrogesterone (D2.5 mg) reduces vasomotor symptoms (VMS). Methods: This study was a post hoc analysis of data from two phase 3, double-blind studies. Postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg, E1 mg/D5 mg (not included in this analysis) or placebo for 13 weeks (European study), or randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks (Chinese study). Endpoints assessed in ethnicity subgroups (European and Chinese) included changes from baseline in number of hot flushes, number of moderate-to-severe hot flushes and Menopause Rating Scale (MRS) score. Results: Overall, 579 women were included in the analysis (E0.5 mg/D2.5 mg, n = 288; placebo, n = 291). European and Chinese women receiving E0.5 mg/D2.5 mg experienced greater reductions from baseline in mean daily number of hot flushes and mean daily number of moderate-to-severe hot flushes at week 4, week 8 and end of treatment versus those receiving placebo. Significant improvements in the 'hot flushes, sweating' MRS item score were reported in both European and Chinese women. Conclusion: Oral, ultra-low-dose continuous combined 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone improved VMS compared with placebo in European and Chinese postmenopausal women, with a positive impact on health-related quality of life. [ABSTRACT FROM AUTHOR]

Abstract To evaluate the association between a first-trimester subchorionic hematoma (SCH) and pregnancy loss before 20 weeks of gestation in singleton pregnancies. We conducted a retrospective cohort study of singleton pregnancies from January to December 2021. All patients had routine first-trimester ultrasound scans and were followed up for pregnancy outcomes. We compared pregnancy loss rates before 20 weeks in women with and without SCH and analyzed risk factors using logistic regression. Out of 1,144 singleton pregnancies, 559 (48.9%) had SCH. Women with SCH had higher rates of vaginal bleeding (38.1 vs. 23.2%, P

Abstract Research question To determine whether the use of oral dydrogesterone (DYD) in luteal phase support (LPS) during an artificial cycle provides equivalent clinical and ongoing pregnancy, delivery and miscarriage rates as micronized vaginal progesterone (MVP) in oocyte donation recipients. Design This was a retrospective observational study of prospectively collected data from the assisted reproductive technology (ART) Department of Lille University Hospital from July 2018 to July 2022. All recipients underwent endometrial preparation by an artificial cycle. Luteal phase support (LPS) was provided by weekly intramuscular progesterone (IM) (500 mg/2 ml) and either DYD (40 mg/day) or MVP (800 mg/day) for 12 weeks if the pregnancy test was positive. The primary endpoint was the clinical pregnancy rate. Results Our study analysed 372 oocyte donation cycles with embryo transfer: 162 embryo transfers with DYD + IM progesterone and 210 embryo transfers with MVP + IM progesterone. After adjustment for confounding factors, our two groups were comparable in terms of clinical pregnancy rates, with 36.7% in the MVP group versus 30.3% in the DYD group (p = 0.55); ongoing pregnancy rates (29,1% versus 25.3%, p = 0.95); miscarriage rates (7.6% versus 4.9%, p = 0.35); and live birth rates (26.7% versus 25.3%, p = 0.86). Conclusion Oral dydrogesterone seems to be a good alternative to vaginal micronized progesterone for LPS treatment during an artificial cycle, especially in combination with a weekly injection of intramuscular progesterone in the course of oocyte donation.

Today, there is an urgent need to develop and implement a regulatory document on abortion. This is due to the catastrophic state of reproduction of the Ukrainian population – the annual decrease in the number of labor, birth rates and the demographic crisis in Ukraine in general. Pregnancy loss not only causes obstetric complications, but also causes significant damage of the mental health of the woman and her partner, including depression and post-traumatic stress disorder. This resolution is a joint position of the leading specialists of Ukraine on the issue of miscarriages based on domestic experience, results of randomized controlled trials and meta-analyses, as well as clinical recommendations of scientific societies of the world. The presented information is designed to help improve clinical approaches to the management of miscarriage in today’s conditions, in order to save every pregnancy and to not lose a baby. During the Forum, the practical issues of diagnosis and treatment of miscarriage, modern management of threatened and habitual miscarriage, hormonal support of pregnant women and the use of progestogens, the influence of the first half of pregnancy on the birth of a healthy child, the impact of liver diseases on the choice of therapy in a pregnant woman, and others issues were considered. World clinical experience has convincingly proven the high effectiveness of progestogens in the therapy of threatened and repeated miscarriages. However, not all progestogens are equally effective in reducing the risk of miscarriage and live birth in case of threatened miscarriage. Micronized progesterone and dydrogesterone are the most effective. Dydrogesterone differs from progesterone in its mechanism of action and affinity for progesterone receptors. A strong evidence base has been accumulated about a high profile of effectiveness and a low frequency of maternal and fetal complications for dydrogesterone, the use of which is approved by leading foreign associations. Drug interactions and their effects on the liver should also be taken into account. Drugs that are indicated for pregnant women should be prescribed in the smallest therapeutic dose, which should be effective.

Objective: To analyze the efficacy of levonorgestrelintrauterine system, Drospirenone & ethinylestradiol tablets (II), and dydrogesterone in preventing the recurrence of endometrial polyps after hysteroscopic endometrial polypectomy. Methods: One hundred seventy patients who underwent hysteroscopic endometrial polypectomy in the Gynecology Department of Tianmen First People's Hospital in Hubei Province from January 2022 to June 2023 were randomly divided into the levonorgestrelintrauterine system group, Drospirenone & ethinylestradiol tablets (II) group, dydrogesterone group, and a control group. The recurrence rates, endometrial thickness, and menstrual volume changes at 6 and 12 months post-operation were compared among these four groups. Results: The recurrence rates in the levonorgestrelintrauterine system group, Drospirenone & ethinylestradiol tablets (II) group, and dydrogesterone group were lower than the control group, with statistical significance (P < 0.01), with the levonorgestrelintrauterine system group having the lowest recurrence rate. The endometrial thickness at 6 and 12 months post-operation in the levonorgestrelintrauterine system group, Drospirenone & ethinylestradiol tablets (II) group, and dydrogesterone group was thinner than that of the control group and thinner than pre-operation, with statistical significance (P < 0.01). The menstrual volume at 3 months post-operation in the levonorgestrelintrauterine system group, Drospirenone & ethinylestradiol tablets (II) group, and dydrogesterone group was significantly less than the control group, and less than the pre-operation volume. Conclusion: Dydrogesterone, drospirenone & ethinylestradiol tablets (II), and levonorgestrelintrauterine system all play a role in preventing the recurrence of endometrial polyps, but levonorgestrelintrauterine system is significantly better than dydrogesterone and Drospirenone & ethinylestradiol tablets (II) in terms of postoperative recurrence rate, endometrial thickness, menstrual changes, and compliance, and is worth promoting in clinical application. [ABSTRACT FROM AUTHOR]

Background and Aims: One of the causes of preterm labor and recurrent abortion is progesterone deficiency in the luteal phase. The aim of the study was a comparison of the effect of oral dydrogesterone and vaginal progesterone for luteal‐phase support (LPS) in assisted reproductive technology cycles (ART). Methods: This randomized clinical control trial study was conducted on 207 infertile women. Samples were randomly divided into two groups. The first group received a natural micronized vaginal progesterone (MVP) of 400 mg once daily and the second group received dydrogesterone (Duphestone) 20 mg twice daily. Then chemical pregnancy, abortion, and live births were compared in two groups. Results: The results of the study showed that the vaginal form of the drug could increase the chance of pregnancy (positive β‐human chorionic gonadotropin) versus the oral form. According to the results of multiple logistic regression analysis after adjusting for other variables, the live birth rate in the vaginal group was more than five times that of the oral group (odds ratio = 5.07; 95% confidence interval = 1.24–20.65; p = 0.023). Conclusion: The vaginal form of the progesterone could increase the chance of pregnancy and the outcome of fertility (live birth). Thus, vaginal progesterone is effective for LPS in women undergoing fresh embryo transfer. [ABSTRACT FROM AUTHOR]

Today, there is an urgent need to develop and implement a regulatory document on abortion. This is due to the catastrophic state of reproduction of the Ukrainian population – the annual decrease in the number of labor, birth rates and the demographic crisis in Ukraine in general. Pregnancy loss not only causes obstetric complications, but also causes significant damage of the mental health of the woman and her partner, including depression and post-traumatic stress disorder. This resolution is a joint position of the leading specialists of Ukraine on the issue of miscarriages based on domestic experience, results of randomized controlled trials and meta-analyses, as well as clinical recommendations of scientific societies of the world. The presented information is designed to help improve clinical approaches to the management of miscarriage in today’s conditions, in order to save every pregnancy and to not lose a baby. During the Forum, the practical issues of diagnosis and treatment of miscarriage, modern management of threatened and habitual miscarriage, hormonal support of pregnant women and the use of progestogens, the influence of the first half of pregnancy on the birth of a healthy child, the impact of liver diseases on the choice of therapy in a pregnant woman, and others issues were considered. World clinical experience has convincingly proven the high effectiveness of progestogens in the therapy of threatened and repeated miscarriages. However, not all progestogens are equally effective in reducing the risk of miscarriage and live birth in case of threatened miscarriage. Micronized progesterone and dydrogesterone are the most effective. Dydrogesterone differs from progesterone in its mechanism of action and affinity for progesterone receptors. A strong evidence base has been accumulated about a high profile of effectiveness and a low frequency of maternal and fetal complications for dydrogesterone, the use of which is approved by leading foreign associations. Drug interactions and their effects on the liver should also be taken into account. Drugs that are indicated for pregnant women should be prescribed in the smallest therapeutic dose, which should be effective. [ABSTRACT FROM AUTHOR]

Purpose This study aimed to compare the efficacies of Femoston and Dydrogesterone therapy in patients with incomplete abortions.Methods Patients with incomplete abortions were included if they preferred medication over surgical intervention. The participants were categorized into three groups: the Femoston group received Femoston, the Dydrogesterone group was administered Dydrogesterone, and the control group was followed up without treatment. Basic clinical information, complete abortion success rate, and menstrual recovery rate were collected to evaluate the efficacy of Femoston and Dydrogesterone in patients with incomplete abortions.Results We analyzed 332 patients with incomplete abortions. The success rate of complete abortion was significantly higher in the Femoston group than in the control group (relative risk (RR)=1.708, 95% CI 1.304–2.237, p = .001) and the Dydrogesterone group (RR = 1.200, 95% CI 1.015–1.418, p = .023). The effectiveness of Dydrogesterone was also significantly higher than that in the control group (RR = 1.439, 95% CI 1.068–1.938, p = .015). After 60 days, the rate of menstrual recovery in the Femoston group was significantly higher than that in the control group (RR =1.322, 95% CI 1.103–1.609, p = .001), while the rate in the Dydrogesterone group was significantly lower than that in the Femoston group (RR =1.200, 95% CI 1.035–1.391, p = .009).Conclusions Femoston and Dydrogesterone were effective in treating incomplete abortions, with Femoston being more effective. Patients receiving Femoston had shorter menstrual recovery times than those receiving dydrogesterone. Therefore, Femoston and Dydrogesterone are potential treatment options for incomplete abortion, with Femoston being the more effective.

Background: Progestin-primed ovarian stimulation (PPOS) stimulates ovaries to block the premature surge of luteinizing hormone (LH) by using micronized progesterone or a progestin during the follicular phase instead of the conventional gonadotropin-releasing hormone (GnRH) analogues or GnRH antagonists downregulating LH to obtain multi-follicle engagement. Current work aims to assess the influence of progestogen treatment on ovarian stimulation and the ability to control LH surge, its efficacy and suitability in retrieving oocytes, without affecting the embryo quality and its benefit among infertile women long-term outcomes on children compared to standard stimulation protocols. Materials and Methods: The literature review used the randomized control trials published in the Pubmed database from January 2015 to April 2021. To generate the citation list, the following keywords were used: ‘progestin-primed ovarian stimulation’, ‘PPOS’, ‘micronized progesterone’, ‘medroxyprogesterone’, and/or ‘dydrogesterone’. The selected articles analyzed the cohort, intervention, and scheme of the progestin-primed ovarian stimulation protocol in controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) used in Assisted Reproductive Technologies (ART). Results: Overall we concluded that PPOS for IVF/ICSI in ART results in a higher number of obtained embryos, lower incidence of OHSS, equal duration of stimulation, number of retrieved oocytes, and number of MII oocytes. It is also suggested that long-term safety in children shows no significant difference between the study and control groups. Conclusions: Despite the outcomes of progestin stimulation cycles among all cohorts, we concluded that poor ovarian responders, patients with PCOS, women of advanced age and oocyte donors benefit the most from using PPOS.

Objective: To assess the safety and tolerability of ultra-low dose estradiol and dydrogesterone (E0.5 mg/D2.5 mg) among postmenopausal women. Methods: This pooled analysis of data from three clinical studies assessed the effects of continuous combined ultra-low-dose estradiol and dydrogesterone among postmenopausal women. Participants received E0.5 mg/D2.5 mg or placebo for 13 weeks (double-blind, randomized, European study), E0.5 mg/D2.5 mg or placebo for 12 weeks (double-blind, randomized, Chinese study), or E0.5 mg/D2.5 mg for 52 weeks (open-label, European study). Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment discontinuation due to a TEAE, and adverse events of special interest (AESIs). Results: Overall, 1027 women were included in the pooled analysis (E0.5 mg/D2.5 mg, n = 736; placebo, n = 291). Mean treatment exposure was 288.9 days in the E0.5 mg/D2.5 mg group and 86.6 days in the placebo group. The proportion of women experiencing ≥1 TEAE was similar in the E0.5 mg/D2.5 mg and placebo groups (50.1% vs 49.5%, respectively). TESAEs occurred in 12 (1.6%) women receiving E0.5 mg/D2.5 mg and 9 (3.1%) women receiving placebo. Discontinuation of study treatment was infrequent in both groups (E0.5 mg/D2.5 mg: 1.5%; placebo: 2.4%). The occurrence of breast pain was more common in the E0.5 mg/D2.5 mg group than in the placebo group (2.0% vs 0.3%) as was uterine hemorrhage (6.5% vs 2.4%). The incidence of acne, hypertrichoses and weight increased was similar between groups. Conclusions: Across three studies, ultra-low-dose estradiol plus dydrogesterone was well tolerated among postmenopausal women, with no increase in TEAEs or TESAEs compared with placebo.

Purpose: To evaluate the effectiveness of the progestin-primed ovarian stimulation (PPOS) protocol versus the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol in ovarian stimulation. Methods: In this retrospective cohort study, we included 804 patients who were treated between January 1st, 2022, and July 1st, 2023. Outcomes of ovarian stimulation were compared between the PPOS (n = 206) and GnRH-ant (n = 598). The primary outcome was the number of good cleavage embryos. Results: Baseline characteristics were comparable in both groups. In both unadjusted and adjusted analysis, the mean number of good cleavage embryos in PPOS (6.33) was non-inferior to GnRH-ant (6.44; unadjusted ratio of two means 1.02, 95%CI 0.92, 1.13). The trigger-day estradiol level in patients with PPOS was higher than in patients with GnRH-ant (4,420 vs 3,830 pg/ml, respectively) despite similar total follicle stimulating hormone dose and fewer days of ovarian stimulation. The number of oocytes, MII oocytes, cleavage and blastocyst embryos were comparable between the two protocols. After the first transfer of embryos, the clinical pregnancy rate and implantation rate were higher in the PPOS group, while the pregnancy rate and ongoing pregnancy were not significantly different. None of the PPOS patients had an unexpected LH surge, and serum LH levels decreased slightly during ovarian stimulation. Conclusions: The PPOS protocol with dydrogesterone provided similar embryo outcomes to the GnRH-ant protocol, with notable distinctions in clinical pregnancy and implantation rate. The serum LH concentration during ovarian stimulation using PPOS was well-controlled.

Purpose: This study aims to evaluate whether the clinical outcomes of cycles with frozen embryo transfer (FET) in hormonal replacement treatment supplemented with dydrogesterone (DYD) following detection of low circulating levels of progesterone (P4) were comparable to the results of cycles with otherwise normal serum P4 values. Methods: Extended analyses of a retrospective cohort that included FET cycles performed between July 2019 and March 2022 after a cycle of artificial endometrial preparation using valerate-estradiol and micronized vaginal P4 (400 mg twice daily). Whenever the serum P4 value was considered low on the morning of the planned transfer, 10 mg of DYD three times a day was added as a supplement. Only single-embryo transfers of a blastocyst were considered. The primary endpoint was live birth rate. Results: Five-hundred thirty-five FET cycles were analyzed, of which 136 (25.4%) underwent treatment with DYD. There were 337 pregnancies (63%), 207 live births (38.6%), and 130 miscarriages (38.5%). The P4 values could be modeled by a gamma distribution, with a mean of 14.5 ng/ml and a standard deviation of 1.95 ng/ml. The variables female age on the day of FET, ethnicity, and weight were associated with a variation in the serum P4 values. There were no differences in the results between cycles with or without the indication for DYD supplementation. Conclusions: Live birth rate did not vary significantly in females with low and normal serum P4 levels on the day of FET when DYD was used as rescue therapy. [ABSTRACT FROM AUTHOR]

• Dydrogesterone, as a near-natural progestin, can inhibit the growth and migration of ectopic endometrium, cause atrophy of ectopic endometrium, and prevent the development of new endometriotic lesions. • It has a good safety profile as it does not inhibit ovulation during administration and does not affect fertility, especially for endometrial patients of reproductive age with fertility requirements. • Therefore, dydrogesterone is expected to be one of the key drugs in the treatment of endometriosis. Endometriosis is a common gynecological disease among women of reproductive age. It is a chronic estrogen and progestin related inflammatory disease. At present, the main treatments for endometriosis are drug therapy and surgery. In drug therapy, progesterone is listed as the first-line recommendation in multinational guidelines. Dydrogesterone, as an oral reversal progesterone, can slow down the metabolism of progesterone, inhibit angiogenesis and extracellular matrix degradation to inhibit the proliferation of the ectopic endometrium, induce the atrophy of the ectopic endometrium through the pro-apoptotic pathway, and treat endometriosis through multiple mechanisms of regulating inflammatory factors to reduce inflammation. Clinically, dydrogesterone treatment of endometriosis can relieve patients' symptoms, promote fertility, be used in combination, and is safe. This article will review the mechanism and clinical application of dydrogesterone in the treatment of endometriosis. [ABSTRACT FROM AUTHOR]

Three successive pregnancy losses before 20 weeks have passed since the last menstrual cycle are considered Recurrent Pregnancy Loss (RPL). Progesterone is crucial for the initiation and maintenance of pregnancy. Due to its well-established safety profile, hormonal therapy with dydrogesterone (Duphaston) is used globally to support luteal function and lower the risk of pregnancy loss in women with URPL. Aim. Estimate the concentration of progesterone, estradiol, progesterone induce blocking factor and epithelial - cadherin in women's with RPL compared to control (fertile women) and known the correlation between them. Methods. Blood samples obtained from (70) women with RPL (35 RPL without treatment and 35 RPL with treatment) from different infertility clinics in Iraq. Also, 36 fertile women's as control. All groups are matched in BMI and age. Result. The concentration of these hormones were significantly decrease (p<0.05) between RPL patients without treatment and controls. While, shown increase of all parameters level in RPL patients with treatment compared with RPL patients without treatment. Regarding the results of correlation were positive correlations between these parameters in patients with treatment and without treatment. Conclusion. This study indicates the importance of dydrogesterone and their positive role in an increasing of hormones level in blood and then lead to increase of other proteins concentrations in patients. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the role of serum progesterone (P4) on the day of embryo transfer (ET) when dydrogesterone (DYD) and micronized vaginal progesterone (MVP) are combined as luteal phase support (LPS) in a hormone replacement therapy (HRT) frozen ET (FET) cycles. Methods: Retrospective study, including single euploid HRT FET cycles with DYD and MVP as LPS and P4 measurement on ET day. Initially, patients with P4 levels < 10 ng/ml increased MVP to 400 mg/day; this "rescue" was abandoned later. Results: 560 cycles of 507 couples were included. In 275 women, serum P4 level was < 10 ng/ml on the ET day. Among those with low P4 levels, MVP dose remained unchanged in 65 women (11.6%) and was increased in 210 women (37.5%). Women with P4 levels ≥ 10 ng/ml continued LPS without modification. Overall pregnancy rates in these groups were 61.5% (40/65), 54.8% (115/210), and 48.4% (138/285), respectively (p = n.s.). Association of serum P4 levels with ongoing pregnancy rates was analyzed in women without any additional MVP regardless of serum P4 levels (n = 350); multivariable analysis (adjusted for age, BMI, embryo quality (EQ)) did not show a significant association of serum P4 levels with OPR (OR 0.96, 95% CI 0.90–1.02; p = 0.185). Using inverse probability treatment weights, regression analysis in the weighted sample showed no significant association between P4 treatment groups and OP. Compared to fair EQ, the transfer of good EQ increased (OR 1.61, 95% CI 1.22–2.15; p = 0.001) and the transfer of a poor EQ decreased the odds of OP (OR 0.73, 95% CI 0.55–0.97; p = 0.029). Conclusion: In HRT FET cycle, using LPS with 300 mg/day MVP and 30 mg/day DYD, it appears that serum P4 measurement and increase of MVP in patients with P4 < 10 ng/ml are not necessary. [ABSTRACT FROM AUTHOR]

To evaluate the effectiveness of the progestin-primed ovarian stimulation (PPOS) protocol versus the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol in ovarian stimulation. In this retrospective cohort study, we included 804 patients who were treated between January 1st, 2022, and July 1st, 2023. Outcomes of ovarian stimulation were compared between the PPOS (n = 206) and GnRH-ant (n = 598). The primary outcome was the number of good cleavage embryos. Baseline characteristics were comparable in both groups. In both unadjusted and adjusted analysis, the mean number of good cleavage embryos in PPOS (6.33) was non-inferior to GnRH-ant (6.44; unadjusted ratio of two means 1.02, 95%CI 0.92, 1.13). The trigger-day estradiol level in patients with PPOS was higher than in patients with GnRH-ant (4,420 vs 3,830 pg/ml, respectively) despite similar total follicle stimulating hormone dose and fewer days of ovarian stimulation. The number of oocytes, MII oocytes, cleavage and blastocyst embryos were comparable between the two protocols. After the first transfer of embryos, the clinical pregnancy rate and implantation rate were higher in the PPOS group, while the pregnancy rate and ongoing pregnancy were not significantly different. None of the PPOS patients had an unexpected LH surge, and serum LH levels decreased slightly during ovarian stimulation. The PPOS protocol with dydrogesterone provided similar embryo outcomes to the GnRH-ant protocol, with notable distinctions in clinical pregnancy and implantation rate. The serum LH concentration during ovarian stimulation using PPOS was well-controlled. [ABSTRACT FROM AUTHOR]

Abstract Background and Aims One of the causes of preterm labor and recurrent abortion is progesterone deficiency in the luteal phase. The aim of the study was a comparison of the effect of oral dydrogesterone and vaginal progesterone for luteal‐phase support (LPS) in assisted reproductive technology cycles (ART). Methods This randomized clinical control trial study was conducted on 207 infertile women. Samples were randomly divided into two groups. The first group received a natural micronized vaginal progesterone (MVP) of 400 mg once daily and the second group received dydrogesterone (Duphestone) 20 mg twice daily. Then chemical pregnancy, abortion, and live births were compared in two groups. Results The results of the study showed that the vaginal form of the drug could increase the chance of pregnancy (positive β‐human chorionic gonadotropin) versus the oral form. According to the results of multiple logistic regression analysis after adjusting for other variables, the live birth rate in the vaginal group was more than five times that of the oral group (odds ratio = 5.07; 95% confidence interval = 1.24–20.65; p = 0.023). Conclusion The vaginal form of the progesterone could increase the chance of pregnancy and the outcome of fertility (live birth). Thus, vaginal progesterone is effective for LPS in women undergoing fresh embryo transfer.

Objective: The purpose of this study is to compare the effects of cyclic oral dydrogesterone treatment and levonorgestrel-releasing intrauterine device (LNG_IUD) on quality of life (QoL) and sexual function in patients diagnosed with abnormal uterine bleeding (AUB). Study design: The study was conducted at the University of Health Sciences Turkey Health Istanbul Kanuni Sultan Süleyman Training and Research Hospital, on 171 sexually active patients, aged 18–45, who were under a minimum of 6 months of treatment for AUB. 85 patients were treated with oral cyclic dydrogesterone, and 86 patients received LNG-IUD. Following a minimum of 6 months of treatment, these patients were recruited to the study and were asked to complete a 36-Item Short Form Survey (SF-36) and the Female Sexual Function Index (FSFI). Results: When the FSFI scores of the patients were compared, it was observed that the total FSFI score was significantly higher in the cyclic dydrogesterone group (p < 0.05). Likewise, it was observed that sexual desire, arousal, and lubrication domains were significantly higher in the cyclic dydrogesterone group (p < 0.05). No significant differences were found between the treatment groups in 7 out of the 8 dimensions of SF-36. The energy/vitality dimension was found to be significantly higher in the cyclic dydrogesterone group. Conclusion: Total FSFI score, as well as sexual desire, arousal, and lubrication scores, were significantly higher in the cyclic dydrogesterone group compared to the LNG-IUD group indicating that cyclic dydrogesterone has a more positive impact on sexual function when compared to LNG-IUD. [ABSTRACT FROM AUTHOR]

STUDY QUESTION How do plasma progesterone (P) and dydrogesterone (D) concentrations together with endometrial histology, transcriptomic signatures, and immune cell composition differ when oral dydrogesterone (O-DYD) or micronized vaginal progesterone (MVP) is used for luteal phase support (LPS)? SUMMARY ANSWER Although after O-DYD intake, even at steady-state, plasma D and 20αdihydrodydrogesterone (DHD) concentrations spiked in comparison to P concentrations, a similar endometrial signature was observed by histological and transcriptomic analysis of the endometrium. WHAT IS KNOWN ALREADY O-DYD for LPS has been proven to be noninferior compared to MVP in two phase III randomized controlled trials. Additionally, a combined individual participant data and aggregate data meta-analysis indicated that a higher pregnancy rate and live birth rate may be obtained in women receiving O-DYD versus MVP for LPS in fresh IVF/ICSI cycles. Little data are available on the pharmacokinetic (PK) profiles of O-DYD versus MVP and their potential molecular differences at the level of the reproductive organs, particularly at the endometrial level. STUDY DESIGN, SIZE, DURATION Thirty oocyte donors were planned to undergo two ovarian stimulation (OS) cycles with dual triggering (1.000 IU hCG + 0.2 mg triptorelin), each followed by 1 week of LPS: O-DYD or MVP, in a randomized, cross-over, double-blind, double-dummy fashion. On both the first and eighth days of LPS, serial blood samples upon first dosing were harvested for plasma D, DHD, and P concentration analyses. On Day 8 of LPS, an endometrial biopsy was collected for histologic examination, transcriptomics, and immune cell analysis. PARTICIPANTS/MATERIALS, SETTING, METHODS All oocyte donors were <35 years old, had regular menstrual cycles, no intrauterine contraceptive device, anti-Müllerian hormone within normal range and a BMI ≤29 kg/m2. OS was performed on a GnRH antagonist protocol followed by dual triggering (1.000 IU hCG + 0.2 mg triptorelin) as soon as ≥3 follicles of 20 mm were present. Following oocyte retrieval, subjects initiated LPS consisting of MVP 200 mg or O-DYD 10 mg, both three times daily. D, DHD, and P plasma levels were measured using liquid chromatography–tandem mass spectrometry. Histological assessment was carried out using the Noyes criteria. Endometrial RNA-sequencing was performed for individual biopsies and differential gene expression was analyzed. Endometrial single-cell suspensions were created followed by flow cytometry for immune cell typing. MAIN RESULTS AND THE ROLE OF CHANCE A total of 21 women completed the entire study protocol. Subjects and stimulation characteristics were found to be similar between groups. Following the first dose of O-DYD, the average observed maximal plasma concentrations (C max) for D and DHD were 2.9 and 77 ng/ml, respectively. The C max for D and DHD was reached after 1.5 and 1.6 h (= T max), respectively. On the eighth day of LPS, the first administration of that day gave rise to a C max of 3.6 and 88 ng/ml for D and DHD, respectively. For both, the observed T max was 1.5 h. Following the first dose of MVP, the C max for P was 16 ng/ml with a T max of 4.2 h. On the eighth day of LPS, the first administration of that day showed a C max for P of 21 ng/ml with a T max of 7.3 h. All 42 biopsies showed endometrium in the secretory phase. The mean cycle day was 23.9 (±1.2) in the O-DYD group versus 24.0 (±1.3) in the MVP group. RNA-sequencing did not reveal significantly differentially expressed genes between samples of both study groups. The average Euclidean distance between samples following O-DYD was significantly lower than following MVP (respectively 12.1 versus 18.8, Mann–Whitney P  = 6.98e−14). Immune cell profiling showed a decrease of CD3 T-cell, γδ T-cell, and B-cell frequencies after MVP treatment compared to O-DYD, while the frequency of natural killer (NK) cells was significantly increased. LIMITATIONS, REASONS FOR CAUTION The main reason for caution is the small sample size, given the basic research nature of the project. The plasma concentrations are best estimates as this was not a formal PK study. Whole tissue bulk RNA-sequencing has been performed not correcting for bias caused by different tissue compositions across biopsies. WIDER IMPLICATIONS OF THE FINDINGS This is the first study comparing O-DYD/MVP, head-to-head, in a randomized design on a molecular level in IVF/ICSI. Plasma serum concentrations suggest that administration frequency is important, in addition to dose, specifically for O-DYD showing a rapid clearance. The molecular endometrial data are overall comparable and thus support the previously reported noninferior reproductive outcomes for O-DYD as compared to MVP. Further research is needed to explore the smaller intersample distance following O-DYD and the subtle changes detected in endometrial immune cells. STUDY FUNDING/COMPETING INTEREST(S) Not related to this work, C.Bl. has received honoraria for lectures, presentations, manuscript writing, educational events, or scientific advice from Abbott, Ferring, Organon, Cooper Surgical, Gedeon-Richter, IBSA, and Merck. H.T. has received honoraria for lectures, presentations, manuscript writing, educational events, or scientific advice from Abbott, Ferring, Cooper Surgical, Gedeon-Richter, Cook, and Goodlife. S.M. has received honoraria for lectures, presentations, educational events, or scientific advice from Abbott, Cooper Surgical, Gedeon-Richter, IBSA, and Merck and Oxolife. G.G. has received honoraria for lectures, presentations, educational events, or scientific advice from Merck, MSD, Organon, Ferring, Theramex, Gedeon-Richter, Abbott, Biosilu, ReprodWissen, Obseva, PregLem, Guerbet, Cooper, Igyxos, and OxoLife. S.V.-S. is listed as inventor on two patents (WO2019115755A1 and WO2022073973A1), which are not related to this work. TRIAL REGISTRATION NUMBER EUDRACT 2018-000105-23 [ABSTRACT FROM AUTHOR]

Clinical outcomes of in vitro fertilization (IVF) have significantly improved over the years with the advent of the frozen–thawed embryo transfer (FET) technique. Ovarian hyperstimulation during IVF cycles causes luteal phase deficiency, a condition of insufficient progesterone. Intramuscular or vaginal progesterone and dydrogesterone are commonly used for luteal phase support in FET. Oral dydrogesterone has a higher bioavailability than progesterone and has high specificity for progesterone receptors. Though micronized vaginal progesterone has been the preferred option, recent data suggest that oral dydrogesterone might be an alternative therapeutic option for luteal phase support to improve clinical outcomes of IVF cycles. Dydrogesterone has a good safety profile and is well tolerated. Its efficacy has been evaluated in several clinical studies and demonstrated to be non-inferior to micronized vaginal progesterone in large-scale clinical trials. Oral dydrogesterone may potentially become a preferred drug for luteal phase support in millions of women undergoing IVF. [ABSTRACT FROM AUTHOR]

Abstract Objective: Despite the literature on dydrogesterone, studies on dydrogesterone utilization patterns are largely lacking in Indian patients. Methods: This was a multi-center, retrospective, observational, cross-sectional, and descriptive study across 817 centers in India. Data of patients who received dydrogesterone in past and provided consent for future use of their medical record for research purpose was were retrieved and analyzed. Results: Data of 7287 subjects (aged 29.55±4.84 years) was analyzed. Threatened abortion was the most common indication for which the subjects received dydrogesterone (46.9%) followed by recurrent pregnancy loss. Polycystic ovary syndrome (PCOS), thyroid disorders and anemia were the most common comorbid conditions and prior pregnancy loss, advanced maternal age and obesity were the most common risk factors seen in subjects who received dydrogesterone. Total 27.5% of subjects received a loading dose of dydrogesterone, and majority (64%) received 40 mg as loading dose. 10 mg dose was used as maintenance or regular dose in 81.4% of the subjects. Twice daily (BID) was the most common dosing frequency (66.6%). The most common concomitant medications being taken by the subjects on dydrogesterone included folic acid (45.1%), iron supplements (30.3%) and calcium and vitamin D3 supplements (25.5%). Another progesterone preparation (oral, injection, vaginal, tubal) other than dydrogesterone was used concurrently in 7.8% of subjects. Conclusion: The study helped to identify the patient population that is benefitted by dydrogesterone and the preferred indications, risk factors, comorbid conditions and concomitant medication used in this patient population at real-life scenario.

Endometriosis affects 10% of all women of reproductive age, i.e. 190 million patients. Ukraine currently does not gather statistics on the incidence of endometriosis, but, at a rough estimate, this number is approximately 280 thousand women and the real number may be higher. Endometriosis has known significant social, medical and economic impact. Therefore, Ukrainian leading specialists in obstetrics and gynecology focus on new treatments for endometriosis, given current scientific data and the needs of patients. The given resolution and algorithms for treatment for endometriosis are the common stand of leading specialists in gynecology in our country and were developed on the basis of modern domestic and foreign data and current clinical guidelines. This resolution aims to improve clinical approaches to the routine practice of treatment for endometriosis. The constant increase in the incidence of endometriosis and its management characteristics allows to conduct an extensive study of the effectiveness and safety profile of various progestogens. In recent years, a number of further evidence have appeared regarding dydrogesterone treatment for endometriosis. New data on the effectiveness of dydrogesterone offer another hormone-based treatment for endometriosis, which is extremely important given the need for long-term and individualized treatment for endometriosis. The Europ ean Society of Human Reproduction and Embryology (ESHRE) states that the degree of pain relief in endometriosis is the same for all hormone-based treatments, but the safety and tolerability profiles of different medicinal products differ, which must be considered. According to the obtained data on the effectiveness and metabolic safety profile of various progestogens and during the discussion, algorithms for dydrogesterone-based treatment for endometriosis were proposed.

Objective: To investigate the relationship between serum progesterone (P) levels on the day of blastocyst transfer and pregnancy outcomes in frozen-thawed embryo transfer (FET) cycles using hormone replacement therapy (HRT) with oral dydrogesterone for strengthened luteal phase support (LPS). Materials and methods: This was a retrospective study including 1176 FET cycles. All patients received 40 mg of intramuscular (IM) P daily for endometrium transformation plus oral dydrogesterone 10 mg BID from transfer day for strengthened LPS. Pregnancy outcomes were compared between serum P levels on the transfer day ≥10 ng/ml and