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Background: Polycystic ovary syndrome (PCOS) is diagnosed when [Formula: see text]2 of the following symptoms are present: ovulation disorder (OD), hyperandrogenism (HA), and polycystic ovary morphology (PCO). Clinical features of PCOS are heterogeneous and there are four clinical phenotypes: A (OD + HA + PCO); B (HA + OD); C (HA + PCO); and D (OD + PCO). Women with a PCOS phenotype that includes severe HA are at increased risk for pregnancy complications. There are currently no data on impact of PCOS phenotypes on in vitro fertilization (IVF) outcomes in Vietnamese women. This study investigated the association between PCOS phenotypes and IVF outcomes. Methods: This is a secondary analysis of a randomized controlled trial conducted in patients with PCOS undergoing IVF at IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam between January 2018 and April 2019. The primary outcome was live birth rate. Results: A total of 192 patients were included, of whom 33 patients had phenotype A (17.2%) and 159 had phenotype D (82.8%); no patients had phenotype B or C. Body mass index was significantly higher in patients with phenotype A than D (25.36 ± 4.78 versus 22.08 ± 3.21, [Formula: see text] = 0.001). There were no differences in laboratory and pregnancy outcomes between patients with phenotypes A and D. The live birth rate was lower in patients with phenotype A versus D, but the between-group difference did not reach statistical significance (33.3% vs. 42.8%, [Formula: see text] = 0.419). Conclusions: The common PCOS phenotypes in Vietnamese women with infertility were A and D. No impact of PCOS phenotypes on IVF treatment outcomes was detected in this secondary analysis; larger studies are needed

PURPOSE: In vitro maturation (IVM) is an alternative to in vitro fertilization (IVF) for women at high risk of developing ovarian hyperstimulation syndrome (OHSS). This study determined the effectiveness and safety of a freeze-only strategy versus fresh embryo transfer (ET) after IVM with a pre-maturation step (CAPA-IVM) in women with a high antral follicle count (AFC). METHODS: This randomized, controlled pilot study (NCT04297553) was conducted between March and November 2020. Forty women aged 18-37 years with a high AFC (≥24 follicles in both ovaries) undergoing one cycle of CAPA-IVM were randomized to a freeze-only strategy with subsequent frozen ET (n = 20) or to fresh ET (n = 20). The primary endpoint was ongoing pregnancy resulting in live birth after the first ET of the started treatment cycle. RESULTS: The ongoing pregnancy rate in the freeze-only group (65%) was significantly higher than that in the fresh ET group (25%; p = 0.03), as was the live birth rate (60% versus 20%; p = 0.02). Clinical pregnancy rate was numerically, but not significantly, higher after frozen versus fresh ET (70% versus 35%; p = 0.06), while the number of day 3 or good quality embryos, endometrial thickness on the day of oocyte pick-up, implantation rate, and positive pregnancy test rate did not differ significantly between groups. No cases of OHSS were observed, and miscarriage and multiple pregnancy rates were similar in the two groups. CONCLUSIONS: These findings suggest that the effectiveness of CAPA-IVM could be improved considerably by using a freeze-only strategy followed by frozen ET in subsequent cycles. TRIAL REGISTRATION NUMBER: NCT04297553 ( www.clinicaltrials.gov ).

STUDY QUESTION Is one cycle of IVM non-inferior to one cycle of conventional in IVF with respect to live birth rates in women with high antral follicle counts (AFCs)? SUMMARY ANSWER We could not demonstrate non-inferiority of IVM compared with IVF. WHAT IS KNOWN ALREADY IVF with ovarian hyperstimulation has limitations in some subgroups of women at high risk of ovarian stimulation, such as those with polycystic ovary syndrome. IVM is an alternative ART for these women. IVM may be a feasible alternative to IVF in women with a high AFC, but there is a lack of data from randomized clinical trials comparing IVM with IVF in women at high risk of ovarian hyperstimulation syndrome. STUDY DESIGN, SIZE, DURATION This single-center, randomized, controlled non-inferiority trial was conducted at an academic infertility center in Vietnam from January 2018 to April 2019. PARTICIPANTS/MATERIALS, SETTING, METHODS In total, 546 women with an indication for ART and a high AFC (≥24 follicles in both ovaries) were randomized to the IVM (n = 273) group or the IVF (n = 273) group; each underwent one cycle of IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering. The primary endpoint was live birth rate after the first embryo transfer. The non-inferiority margin for IVM versus IVF was −10%. MAIN RESULTS AND THE ROLE OF CHANCE Live birth after the first embryo transfer occurred in 96 women (35.2%) in the IVM group and 118 women (43.2%) in the IVF group (absolute risk difference –8.1%; 95% confidence interval (CI) –16.6%, 0.5%). Cumulative ongoing pregnancy rates at 12 months after randomization were 44.0% in the IVM group and 62.6% in the IVF group (absolute risk difference –18.7%; 95% CI –27.3%, –10.1%). Ovarian hyperstimulation syndrome did not occur in the IVM group, versus two cases in the IVF group. There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications. LIMITATIONS, REASONS FOR CAUTION The main limitation of the study was its open-label design. In addition, the findings are only applicable to IVM conducted using the prematuration step protocol used in this study. Finally, the single ethnicity population limits the external generalizability of the findings. WIDER IMPLICATIONS OF THE FINDINGS Our randomized clinical trial compares live birth rates after IVM and IVF. Although IVM is a viable and safe alternative to IVF that may be suitable for some women seeking a mild ART approach, the current study findings approach inferiority for IVM compared with IVF when cumulative outcomes are considered. Future research should incorporate multiple cycles of IVM in the study design to estimate cumulative fertility outcomes and better inform clinical decision-making. STUDY FUNDING/COMPETING INTEREST(S) This work was partly supported by Ferring grant number 000323 and funded by the Vietnam National Foundation for Science and Technology Development (NAFOSTED) and by the Fund for Research Flanders (FWO). LNV has received speaker and conference fees from Merck, grant, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring; TMH has received speaker fees from Merck, Merck Sharp and Dohme, and Ferring; RJN has received conference and scientific board fees from Ferring, is a minor shareholder in an IVF company, and receives grant funding from the National Health and Medical Research Council (NHMRC) of Australia; BWM has acted as a paid consultant to Merck, ObsEva and Guerbet, and is the recipient of grant money from an NHMRC Investigator Grant; RBG reports grants and fellowships from the NHMRC of Australia; JS reports lecture fees from Ferring Pharmaceuticals, Biomérieux, Besins Female Healthcare and Merck, grants from Fund for Research Flanders (FWO), and is co-inventor on granted patents on CAPA-IVM methodology in the US (US10392601B2) and Europe (EP3234112B1); TDP, VQD, VNAH, NHG, AHL, THP and RW have no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work. TRIAL REGISTRATION NUMBER NCT03405701 (www.clinicaltrials.gov). TRIAL REGISTRATION DATE 16 January 2018. DATE OF FIRST PATENT’S ENROLMENT 25 January 2018.

STUDY QUESTION We aim to develop, disseminate and implement a minimum data set, known as a core outcome set, for future male infertility research. WHAT IS KNOWN ALREADY Research into male infertility can be challenging to design, conduct and report. Evidence from randomized trials can be difficult to interpret and of limited ability to inform clinical practice for numerous reasons. These may include complex issues, such as variation in outcome measures and outcome reporting bias, as well as failure to consider the perspectives of men and their partners with lived experience of fertility problems. Previously, the Core Outcome Measure for Infertility Trials (COMMIT) initiative, an international consortium of researchers, healthcare professionals and people with fertility problems, has developed a core outcome set for general infertility research. Now, a bespoke core outcome set for male infertility is required to address the unique challenges pertinent to male infertility research. STUDY DESIGN, SIZE, DURATION Stakeholders, including healthcare professionals, allied healthcare professionals, scientists, researchers and people with fertility problems, will be invited to participate. Formal consensus science methods will be used, including the modified Delphi method, modified Nominal Group Technique and the National Institutes of Health’s consensus development conference. PARTICIPANTS/MATERIALS, SETTING, METHODS An international steering group, including the relevant stakeholders outlined above, has been established to guide the development of this core outcome set. Possible core outcomes will be identified by undertaking a systematic review of randomized controlled trials evaluating potential treatments for male factor infertility. These outcomes will be entered into a modified Delphi method. Repeated reflection and re-scoring should promote convergence towards consensus outcomes, which will be prioritized during a consensus development meeting to identify a final core outcome set. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes. STUDY FUNDING/COMPETING INTEREST(S) This work has been supported by the Urology Foundation small project award, 2021. C.L.R.B. is the recipient of a BMGF grant and received consultancy fees from Exscentia and Exceed sperm testing, paid to the University of Dundee and speaking fees or honoraria paid personally by Ferring, Copper Surgical and RBMO. S.B. received royalties from Cambridge University Press, Speaker honoraria for Obstetrical and Gynaecological Society of Singapore, Merk SMART Masterclass and Merk FERRING Forum, paid to the University of Aberdeen. Payment for leadership roles within NHS Grampian, previously paid to self, now paid to University of Aberdeen. An Honorarium is received as Editor in Chief of Human Reproduction Open. M.L.E. is an advisor to the companies Hannah and Ro. B.W.M. received an investigator grant from the NHMRC, No: GNT1176437 is a paid consultant for ObsEva and has received research funding from Ferring and Merck. R.R.H. received royalties from Elsevier for a book, consultancy fees from Glyciome, and presentation fees from GryNumber Health and Aytu Bioscience. Aytu Bioscience also funded MiOXYS systems and sensors. Attendance at Fertility 2020 and Roadshow South Africa by Ralf Henkel was funded by LogixX Pharma Ltd. R.R.H. is also Editor in Chief of Andrologia and has been an employee of LogixX Pharma Ltd. since 2020. M.S.K. is an associate editor with Human Reproduction Open. K.Mc.E. received an honoraria for lectures from Bayer and Pharmasure in 2019 and payment for an ESHRE grant review in 2019. His attendance at ESHRE 2019 and AUA 2019 was sponsored by Pharmasure and Bayer, respectively. The remaining authors declare no competing interests. TRIAL REGISTRATION NUMBER Core Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586. TRIAL REGISTRATION DATE N/A. DATE OF FIRST PATIENT’S ENROLMENT N/A.

STUDY QUESTION Does the addition of oral dydrogesterone to vaginal progesterone as luteal phase support improve pregnancy outcomes during frozen embryo transfer (FET) cycles compared with vaginal progesterone alone? SUMMARY ANSWER Luteal phase support with oral dydrogesterone added to vaginal progesterone had a higher live birth rate and lower miscarriage rate compared with vaginal progesterone alone. WHAT IS KNOWN ALREADY Progesterone is an important hormone that triggers secretory transformation of the endometrium to allow implantation of the embryo. During IVF, exogenous progesterone is administered for luteal phase support. However, there is wide inter-individual variation in absorption of progesterone via the vaginal wall. Oral dydrogesterone is effective and well tolerated when used to provide luteal phase support after fresh embryo transfer. However, there are currently no data on the effectiveness of luteal phase support with the combination of dydrogesterone with vaginal micronized progesterone compared with vaginal micronized progesterone after FET. STUDY DESIGN, SIZE, DURATION Prospective cohort study conducted at an academic infertility center in Vietnam from 26 June 2019 to 30 March 2020. PARTICIPANTS/MATERIALS, SETTING, METHODS We studied 1364 women undergoing IVF with FET. Luteal support was started when endometrial thickness reached ≥8 mm. The luteal support regimen was either vaginal micronized progesterone 400 mg twice daily plus oral dydrogesterone 10 mg twice daily (second part of the study) or vaginal micronized progesterone 400 mg twice daily (first 4 months of the study). In women with a positive pregnancy test, the appropriate luteal phase support regimen was continued until 7 weeks’ gestation. The primary endpoint was live birth after the first FET of the started cycle, with miscarriage MAIN RESULTS AND THE ROLE OF CHANCE The vaginal progesterone + dydrogesterone group and vaginal progesterone groups included 732 and 632 participants, respectively. Live birth rates were 46.3% versus 41.3%, respectively (rate ratio [RR] 1.12, 95% CI 0.99–1.27, P = 0.06; multivariate analysis RR 1.30 (95% CI 1.01–1.68), P = 0.042), with a statistically significant lower rate of miscarriage at LIMITATIONS, REASONS FOR CAUTION The main limitations of the study were the open-label design and the non-randomized nature of the sequential administration of study treatments. However, our systematic comparison of the two strategies was able to be performed much more rapidly than a conventional randomized controlled trial. In addition, the single ethnicity population limits external generalizability. WIDER IMPLICATIONS OF THE FINDINGS Our findings study suggest a role for oral dydrogesterone in addition to vaginal progesterone as luteal phase support in FET cycles to reduce the miscarriage rate and improve the live birth rate. Carefully planned prospective cohort studies with limited bias could be used as an alternative to randomized controlled clinical trials to inform clinical practice. STUDY FUNDING/COMPETING INTERESTS This study received no external funding. LNV has received speaker and conference fees from Merck, grant, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring; TMH has received speaker fees from Merck, Merck Sharp and Dohme, and Ferring; R.J.N. has received scientific board fees from Ferring and receives grant funding from the National Health and Medical Research Council (NHMRC) of Australia; BWM has acted as a paid consultant to Merck, ObsEva and Guerbet, and is the recipient of grant money from an NHMRC Investigator Grant. TRIAL REGISTRATION NUMBER NCT0399876.

Research question How do costs and effects of in-vitro maturation (IVM) compare to IVF in women with a high antral follicle count (AFC)? Design This cost-effectiveness analysis (CEA) was based on data of a previous retrospective cohort study at IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam. Between July 2015 and December 2017, 608 women underwent IVM and 311 women IVF. The effectiveness measure for the CEA was cumulative live birth rate (LBR) after one completed cycle including subsequent cryo-cycles within 12 months of inclusion. Data were collected on resource use related to treatment, medication and pregnancy from the case report forms. The mean costs and effects, average cost differences and incremental cost-effectiveness ratios (ICER) were calculated using non-parametric bootstrap resampling to assess the effect of uncertainty in the estimates. Results Cumulative LBR after one completed cycle were 239/608 (39.3%) in the IVM group versus 155/311 (49.8%) in the IVF group (adjusted odds ratio 0.52, 95% confidence interval [CI] 0.30–0.89). Ovarian hyperstimulation syndrome (OHSS) did not occur in the IVM group versus 11/311 (3.5%) in the IVF group. The mean costs per couple were €4300 (95% CI €1371–18,798) for IVM and €6493 (95% CI €2204–20,136) for IVF. The ICER per additional live birth with IVF was €20,144 (95% CI €9116–50,418). Results were robust over a wide range of assumptions. Conclusions IVM is less expensive than IVF in women with a high AFC undergoing treatment with assisted reproductive technology, while leading to a slightly lower effectiveness in terms of cumulative LBR.

IVF carries a considerable physical, emotional and financial burden. Therefore, it would be useful to be able to predict the likelihood of success for each couple. The aim of this retrospective cohort study was to develop a prediction model to estimate the probability of a live birth at 12 months after one completed IVF cycle (all fresh and frozen embryo transfers from the same oocyte retrieval). We analyzed data collected from 2600 women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) at a single center in Vietnam between April 2014 and December 2015. All patients received gonadotropin-releasing hormone (GnRH) antagonist stimulation, followed by fresh and/or frozen embryo transfer (FET) on Day 3. Using Cox regression analysis, five predictive factors were identified: female age, total dose of recombinant follicle stimulating hormone used, type of trigger, fresh or FET during the first transfer, and number of subsequent FET after the first transfer. The area under the receiver operating characteristics curve for the final model was 0.63 (95% confidence interval [CI] 0.60‒0.65) and 0.60 (95% CI 0.57‒0.63) for the validation cohort. There was no significant difference between the predicted and observed probabilities of live birth (Hosmer-Lemeshow test, p > 0.05). The model developed had similar discrimination to existing models and could be implemented in clinical practice.

Purpose Standard oocyte in vitro maturation (IVM) usually results in lower pregnancy rates than in vitro fertilization (IVF). IVM preceded by a prematuration step improves the acquisition of oocyte developmental competence and can enhance embryo quality (EQ). This study evaluated the effectiveness of a biphasic culture system incorporating prematuration and IVM steps (CAPA-IVM) versus standard IVM in women with polycystic ovarian morphology (PCOM). Methods Eighty women (age n = 40) or standard IVM (n = 40). CAPA-IVM uses two steps: a 24-h prematuration step with C-type natriuretic peptide-supplemented medium, then 30 h of culture in IVM media supplemented with follicle-stimulating hormone and amphiregulin. Standard IVM was performed using routine protocols. Results A significantly higher proportion of oocytes reached metaphase II at 30 h after CAPA-IVM versus standard IVM (63.6 vs 49.0; p p = 0.11). Clinical pregnancy rate per embryo transfer was 63.2% in the CAPA-IVM versus 38.5% in the standard IVM group (p = 0.04). Live birth rate per embryo transfer was not statistically different between the CAPA-IVM and standard IVM groups (50.0 vs 33.3% [p = 0.17]). No malformations were reported and birth weight was similar in the two treatment groups. Conclusions Use of the CAPA-IVM system significantly improved maturation and clinical pregnancy rates versus standard IVM in patients with PCOM. Furthermore, live births after CAPA-IVM are reported for the first time.

STUDY QUESTION What is the early luteal phase hormonal profile in patients undergoing ovarian stimulation for IVF/ICSI followed by hCG trigger and a freeze-all strategy without luteal phase support? SUMMARY ANSWER The peak concentration of progesterone occurred 4 days after oocyte pick-up (OPU + 4), with an average 35% fall from OPU + 4 to OPU + 6, and progesterone levels before and 12 h after hCG administration predicted levels during the early luteal phase. WHAT IS KNOWN ALREADY The luteal phase during IVF differs from that during normal cycles, particularly with respect to the serum progesterone level profile. This can cause asynchrony between the embryo and the endometrium, potentially resulting in implantation failure and poor reproductive outcomes. STUDY DESIGN, SIZE, DURATION This prospective study included 161 women with normal ovarian reserve receiving GnRH antagonist co-treatment during ovarian stimulation with FSH who were followed up to 6 days after OPU in a single IVF cycle. PARTICIPANTS/MATERIALS, SETTING, METHODS Women aged 18–42 years undergoing IVF with ovarian stimulation using FSH were included. Ovulation was triggered with recombinant hCG 250 μg. Hormone levels were determined from blood samples taken on the day of trigger, before hCG, at 12, 24 and 36 h after hCG and at 1, 2, 3, 4, 5 and 6 days after OPU. The primary endpoint was early luteal phase serum concentrations of progesterone, LH, estradiol and hCG. MAIN RESULTS AND THE ROLE OF CHANCE One outlier with a pre-hCG serum progesterone level of 11.42 ng/mL was excluded, so all analyses included 160 subjects. Progesterone levels began to increase 1 day after OPU, peaked 4 days after OPU (114 ng/mL), then declined from OPU + 5 onwards. Peak progesterone levels were at OPU + 4, OPU + 5 or OPU + 6 in 38.8, 29.4 and 13.8% of patients, respectively. Approximately two-thirds of patients had a fall in serum progesterone from OPU + 4 to OPU + 6. Pre-hCG progesterone levels correlated significantly with those at 24 h after hCG (r2 = 0.28; P LIMITATIONS, REASONS FOR CAUTION The influence of different profiles of serum progesterone on reproductive outcomes could not be determined because a freeze-all strategy was used in all patients. In addition, data were not available to relate serum hormone level findings with endometrial histology or endometrial receptivity analysis to clearly identify the relationship between serum hormones and the window of implantation. WIDER IMPLICATIONS OF THE FINDINGS Detailed information about early luteal phase hormone levels could be used to optimize and individualize luteal phase support to improve reproductive outcomes. STUDY FUNDING/COMPETING INTEREST(S) This study was funded by My Duc Hospital, Ho Chi Minh City, Vietnam. All authors state that they have no conflicts of interest to disclose. TRIAL REGISTRATION NUMBER NCT02798146; NCT03174691.

STUDY QUESTION: What is the effectiveness and safety of IVM compared with IVF for the treatment of women with high antral follicle count (AFC)? SUMMARY ANSWER: In women with high AFC undergoing assisted reproductive technique (ART), IVM is an effective alternative compared with IVF, while it eliminates the risk of ovarian hyperstimulation syndrome (OHSS). WHAT IS KNOWN ALREADY: IVM is postulated to be an alternative to conventional IVF to avoid OHSS. It has particular potential in women with high AFC who are known to be at increased risk of OHSS. To date, IVM and IVF have only been compared in small cohort studies. STUDY DESIGN, SIZE AND DURATION: We performed a retrospective cohort study including 919 women, of whom 608 underwent IVM and 311 IVF. The treatments were conducted at IVFMD, My Duc Hospital, Ho Chi Minh, Vietnam, from July 2015 to December 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS: We studied infertile women aged 18-38 years with an indication for ART and with an AFC ≥24. Women received either IVM or IVF treatment depending on patient's or physician's preference. In IVM cycles, women received 3 days of FSH 100 IU/day followed by hCG 10 000 IU. In IVF cycles, women underwent a gonadotropin-releasing hormone antagonist protocol and were triggered with hCG 6500 IU. Outcome measures were live birth rate (LBR) after first embryo transfer and cumulative LBR after one complete cycle, defined as the chance of having live birth after all fresh and frozen transfers of embryos derived from one IVM/IVF cycle. We also report on clinical pregnancy, miscarriage, multiple pregnancy and OHSS. MAIN RESULTS AND THE ROLE OF CHANCE: Baseline characteristics including age and BMI were comparable between groups. In the IVM group (608 started cycles), there were 511 fresh and 167 frozen transfers. In the IVF group (311 started cycles), there were 209 fresh and 185 frozen transfers. The number of mature oocytes, embryos, good embryos and frozen embryos was significantly lower in the IVM compared with the IVF group. LBRs after the first transfer were 222/608 (36.5%) versus 127/311 (40.8%) (adjusted odds ratio [OR], 0.74; 95% confidence interval [CI], 0.42-1.30). Cumulative LBRs after one completed cycle were 239/608 (39.3%) versus 155/311 (49.8%) (adjusted OR, 0.52; 95% CI, 0.30-0.89). OHSS did not occur in the IVM group versus 11/311 (3.5%) in the IVF group. LIMITATIONS AND REASONS FOR CAUTION: Our study is limited by its non-randomized design. Randomized clinical trials are required to precisely compare the outcomes after IVM versus IVF. WIDER IMPLICATIONS OF THE FINDINGS: In infertile women with a high AFC, IVM is a feasible alternative to standard IVF that markedly reduces OHSS and is potentially more patient friendly and cost effective. STUDY FUNDING/COMPETING INTEREST(S): No external funding was sought to support this work. B.W.M. is supported by a National Health Medical Research Council Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck and Guerbet. All other authors have no conflicts of interest.NA.

PURPOSE: To investigate the effectiveness of a biphasic IVM culture strategy at improving IVM outcomes in oocytes from small follicles (

IntroductionIn vitro maturation (IVM) is a potential alternative to conventional in vitro fertilisation (IVF) to avoid ovarian hyperstimulation syndrome (OHSS). This is particularly relevant in women with a high antral follicle count (AFC) and/or polycystic ovary syndrome (PCOS), who are at increased risk for OHSS. However, no randomised controlled trials of IVM versus IVF in women with high AFC have reported both pregnancy and OHSS rates. The aim of this study is to compare the effectiveness and safety of one IVM cycle and one IVF with segmentation cycle within women with PCOS or high AFC-related subfertility.Methods and analysisThis randomised controlled trial will be conducted at a specialist IVF centre in Vietnam. Eligible subfertile women with PCOS and/or high AFC will be randomised to undergo either IVM or IVF. The primary outcome is live birth after the first embryo transfer of the started treatment cycle. Cycles in which no embryo is available for transfer will be considered as failures. The study has a non-inferiority design, with a maximal acceptable between-group difference of 5%. Rates of OHSS will also be reported.Ethics and disseminationEthical approval was obtained from the participating centre, and informed patient consent was obtained before study enrolment. Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03405701; Pre-results.

Research question What are the roles of serum progesterone and endometrial thickness as biomarkers in the decision between a freeze-only and fresh embryo transfer in IVF for women without polycystic ovary syndrome (PCOS)? Design This was a secondary analysis of a randomized controlled trial including 782 couples who were followed up until the end of the first completed cycle. Couples scheduled for their first or second IVF cycle with a FSH/gonadotrophin-releasing hormone antagonist protocol were randomized to a freeze-only (n = 391) or fresh embryo transfer (n = 391) strategy. The endpoint for this analysis was live birth rate (LBR) after the first embryo transfer. Results There was no significant difference in LBR after the first cycle between a freeze-only and fresh transfer strategy. When serum progesterone levels at trigger were in the third quartile (Q3, 1.14–1.53 ng/ml), LBR was significantly higher in the freeze-only versus fresh transfer group (P = 0.01); when serum progesterone was ≥1.14 ng/ml, LBR was significantly better in the freeze-only group (37.4% versus 23.8% in the fresh transfer group; P = 0.004). LBRs in the freeze-only and fresh embryo transfer groups were similar across all quartiles of endometrial thickness, although a small advantage for freeze-only in women with a very thin endometrium could not be excluded. Conclusions Serum progesterone level on the day of trigger may have potential as a biomarker on which to base a prospective decision about whether to use a freeze-only or fresh embryo transfer strategy in women undergoing IVF.

Background In vitro maturation (IVM) has some advantages over conventional in vitro fertilization (IVF), particularly in polycystic ovary syndrome (PCOS) where the risk of ovarian hyperstimulation is high. We studied the live birth rate in a large series of PCOS women undergoing human chorionic gonadotropin (hCG)-priming IVM. Methods This retrospective study included women with PCOS aged 18–42 years undergoing IVM with hCG priming. We reported live birth rate after the first embryo transfer and cumulative live birth rate from embryos obtained in the IVM cycle. We also performed logistic regression to assess which factors predicted number of oocytes and live birth. Results We included 921 women (age 28.9±3.5 years, body mass index 21.8±3.1 kg/m2, infertility duration 3.7±2.6 years, 81% primary infertility, 88% first IVF attempt, 94% ovulation induction failure). Live birth rate after the first embryo transfer was 31.7%, with a cumulative live birth rate from the cycle of 33.7%. High anti-Müllerian hormone levels predicted a high number of oocytes and a high oocyte maturation rate while the opposite was the case when luteinizing hormone levels were high. Conclusions In women with PCOS, hCG priming IVM was feasible and resulted in acceptable live birth rates.