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Objective: To explore the effectiveness, safety and cost between urinary follicle stimulating hormone (uFSH) and recombinant follicle stimulating hormone (rFSH) in controlled ovarian stimulation (COS) in China. Methods: Data were collected from 16 reproductive centers in China covering oocytes collection time from May 1, 2015 to June 30, 2018. Eligible patients were over 18 years old, adopting COS with uFSH (uFSH group) or rFSH (rFSH group) as start gonadotropins (Gn), and using in vitro fertilization (IVF) and (or) intracytoplasmic sperm injection for fertilisation, excluding frozen embryo recovery cycle. Generalised estimating equation was used to address the violation of independency assumption between cycles due to multiple IVF cycles for one person and clustering nature of cycles carried out within one center. Controlling variables included age, body mass index, anti-Müllerian hormone level, cause of infertility, ovulation protocol, type of fertilisation, number of embryos transferred, number of days of Gn use. Results: Totally 102 061 cycles met eligibility criteria and were included in the analyses. In terms of effectiveness, after controlling relevant unbalanced baseline characteristics, compared with rFSH group, the high oocyte retrieval (>15 oocytes was considered high retrieval) rate of uFSH group significantly decreased in gonadotropin-releasing hormone agonist protocol ( OR =0.642, P <0.01) and in gonadotropin-releasing hormone antagonist protocol ( OR =0.556, P =0.001), but the clinical pregnancy rate per transfer cycle and the live birth rate per transfer cycle significantly increased ( OR =1.179, OR =1.169, both P <0.01) in both agonist and antagonist protocols. For safety, multiple analysis result demonstrated that in the agonist protocol, compared with rFSH group, the incidence of moderate to severe ovarian hyperstimulation syndrome of uFSH group significantly decreased ( OR =0.644, P =0.002). The differences in ectopic pregnancy rate and multiple pregnancy rate between the uFSH and rFSH groups were not significant ( P =0.890, P =0.470) in all patients. In terms of cost, compared with rFSH group, the uFSH group had lower total Gn costs for each patient ( P <0.01). Conclusion: For patients who underwent COS, uFSH has better safety, and economic profiles over rFSH in China.

Objective: To investigate the effect of domestic urine-derived high-purity follicle- stimulating hormone (HP-FSH, Lishenbao) on the outcome of in vitro fertilization(IVF) embryo transfer (ET) in controlled ovarian stimulation (COS)., Methods: From 1 September 2010 to 31 March 2011, total of 3178 infertility patients from 14 Reproductive Center with IVF or intracytoplasmic sperm injection (ICSI) indications who accepted first IVF or ICSI cycle were studied retrospectively. Their causes of infertility include all infertility factors except ovulatory dysfunction infertility and uterine factor infertility. The only long luteal phase gonadotropin-releasing hormone agonist (GnRH-a) protocol was included. Patients were divided into 2 groups according to the type of follicle-stimulating hormone (FSH) agents used: 1932 cases in HP-FSH group and 1246 cases in recombinant FSH (rFSH)group. Patients in both groups were combined with human menopausal gonadotropin (hMG) at doses of 150 U when follicle with diameter reached to 14-16 mm. When 3 dominate follicle with diameter reached 18 mm, hCG at dose of 5000 to 10 000 U or recombinant hCG at dose of 250 µg was administered by intramuscular injection. After 34 to 36 hours, oocytes were obtained guided by ultrasound, then IVF-ET were underwent in their Reproductive Center. The primary endpoint was comparison of live birth rate between the two groups. The secondary endpoints were comparisons of clinical pregnancy rate, miscarriage rate, and implantation rate, as well as COS and IVF outcome between the two groups., Results: (1) There were significantly differences in baseline characteristics of the patients between two groups. The mean age was elder(32 ± 4 versus 30 ± 4, P < 0.01) , the infertility duration was longer (5 ± 4 versus 5 ± 3, P < 0.01) , and antral follicle count (AFC) was less (11 ± 5 versus 13 ± 7, P < 0.01) in patients of HP-FSH group compared with those in patients of rFSH group. (2) As compared with rFSH, the total doses of gonadotropin needed was (2348 ± 1011) U in HP-FSH group versus (2022 ± 659) U in rFSH group, the number of oocytes 13 ± 6 in HP-FSH group and 14 ± 7 in rFSH group, the rate of embryo frozen cycle of 66.30% (1281/1932) in HP-FSH group and 74.88% (933/1246) in rFSH group, which all reached statistical difference (P < 0.01). However, there were no significant different implantation rate [30.49% (1111/3644) versus 32.45% (737/2271)] between two groups. The other clinical parameters did not show significant difference, including clinical pregnancy rate per started cycle [41.61% (804/1932) versus 41.97% (523/1246) ] , clinical pregnancy rate per ET cycle[46.58% (804/1726) versus 48.47% (523/1079)], live birth rate per started cycle[34.21% (661/1932) versus 34.19% (426/1246)], live birth rate per ET cycle [38.30% (661/1726) versus 39.48% (426/1079)], miscarriage rate[13.6% (109/804) versus 16.4% (86/523)], and moderate/severe ovarian hyperstimulation syndrome (OHSS) rate [5.80% (112/1932) versus 7.78% (97/1246)](P > 0.05).(3) Treatment cost: the cost of gonadotropins needed for the patients in HP-FSH group was lower than that in rFSH group (4005 ± 1650 versus 6482 ± 2095, P < 0.01)., Conclusion: In IVF/ICSI treatment cycles, domestic HP-FSH has similar live birth rate and lower financial burden when compared with rFSH.

Objectives: To observe the genetic characteristics of chromosomes and the rates of implantation and pregnancy in couples of translocation carriers who undergo preimplantation genetic diagnosis (PGD) and to evaluate the significance of PGD in the treatment of translocation carriers., Methods: Fluorescence in situ hybridization (FISH) was performed to analyze the embryos of 12 carriers of reciprocal translocation and 22 carriers of Robertsonian translocation. The results of diagnosis and the implantation and pregnancy rates were analyzed., Results: A total of 253 embryos from 36 couples were retrieved and FISH was applied for the examination. The characteristics of chromosomes were diagnosed in 225 embryos and the rate of successful PGD was 88.9%. Fifty-eight embryos were found to have normal chromosome or balanced translocation and were transferred into the uterus. The rate of implantation was 36% (5/14) and 14% (6/44) and the rate of pregnancy was 4/9 and 26% (5/19) for carriers of Robertsonian translocation and reciprocal translocation, respectively., Conclusions: The FISH-based PGD is effective in the diagnosis of Robertsonian translocation and reciprocal translocation of embryos. It provides the possibility of a high rate of implantation and pregnancy, and avoids recurrent abortion and unwilling termination of pregnancy.

Objective: To compare the efficacy and safety of tranexamic acid (TA) and norethisterone (NET) for the treatment of patients with ovulatory menorrhagia in China., Methods: One hundred and thirty one patients with proven ovulatory menorrhagia from gynecologic clinics of 5 teaching hospitals located in 4 different cities in China were enrolled during Jul 2004 to Dec 2006. Among them 128 completed the study. Patients were randomly divided into two therapeutic regimen groups: TA 1 g thrice daily during menstrual cycle days (D) 1-5, 69 cases; or NET 5 mg twice daily on D19-26, 59 cases. The drugs were administered for 2 consecutive cycles, then withdrawn and patients were followed-up for 1 more cycle. Data on menstrual blood loss [estimated by pictorial blood assessment chart (PBAC)], length of menstrual periods, quality of life (QOL) evaluated by a 6 item health-related questionnaire were collected before, during each cycle and were compared., Results: Both treatments led to significant decreases of mean PBAC scores and shorter duration of menstrual periods, and improved the QOL ranking during the two treatment cycles. The mean percentages of PBAC decrements in the TA first and second cycles were significantly greater than those in the NET corresponding cycles(35% vs 17% , P = 0.004; 44% vs 34%, P = 0.04 respectively). The success rate of TA second cycle was higher than that of the NET second cycle (41% vs 24%, P = 0.04). Improvement of QOL ranking in the TA first cycle was also significantly better than those in the NET first cycle (P = 0.03). The percentage of patients with at least 1 adverse event in TA group (19%) was significantly lower than that in NET group (35%, P = 0.04). Patients' willingness to continue the treatment in the TA second and follow-up cycles (94%, 79% respectively) were significantly higher than those in the corresponding cycles of NET groups (79%, 59% respectively; P = 0.01, P = 0.02)., Conclusion: The regimen of TA 3 g daily during menstrual days 1-5 is a more effective and tolerable treatment than luteal phase norethisterone for patients with ovulatory menorrhagia.

Objective: To determine the clinical characteristics and management of ovarian tumor in infertility women., Methods: During the period from Jan. 1 1999 to Dec. 31 2004, 110 infertility women with ovarian tumor were analysed retrospectively, in terms of clinical and pathological features. According to the histological findings, the tumors were divided into three groups: epithelial tumor, teratoma and others., Results: Among 110 cases, 49 cases were epithelial tumor, 42 cases were teratoma, and 19 cases were others. A total of 97 cases were small ovarian tumor, and the maximal diameter was less than 5 cm. In epithelial tumor group only 29% were diagnosed before operation, significantly lower than the other two groups (P < 0.01). In epithelial tumor group 61% were complicated with pelvic inflammatory disease (PID), significantly higher than teratoma group (26%, P < 0.01). A total of 102 cases (91%) were followed-up for 1.5 to 5 years. A total of 45 patients (44%) had become pregnant. Among them 18 conceived spontaneously, 21 underwent in vitro fertilization-embryo transfer, and 6 received artificial insemination., Conclusions: Most ovarian tumors found in infertility women are small cysts and only a few epithelial tumors are diagnosed before the operation. Physicians should be alert of infertility women with ovarian mass and laparoscopy should be performed as early as possible. Our data show the incidence of PID in epithelial tumor group is higher than others. After treatment by surgery and assisted reproductive technology, those infertility women with ovarian tumor may achieve fair pregnancy outcomes.

Objective: To investigate whether the limited ovarian stimulation (LOS) could avoid the severe ovarian hyperstimulation syndrome (OHSS) in patients with high risk of OHSS., Methods: Ten infertile patients were diagnosed as polycystic ovarian syndrome (PCOS) with high risk of OHSS. All of them were arranged LOS cycles, a long-induction protocol using gonadotropin releasing hormone agonist (GnRHa) for controlled ovarian hyperstimulation. A full dose of human chorionic gonadotropin (10,000 U) was administered when the leading follicle reached a mean diameter of 12.0 - 14.5 mm. Oocytes were retrieved 36 hours later, followed by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) and embryo transfer., Results: Ten patients produced 11 - 35 oocytes, including 4 - 28 oocytes of metaphase II. Embryos were transferred in all of ten patients and eight clinical pregnancies were diagnosed. Unfortunately, ectopic pregnancy occurred in one of the patients. None of them experienced the symptoms of OHSS., Conclusions: LOS may play a valuable role in preventing OHSS and achieving enough mature oocytes for the patients of PCOS. Furthermore, this protocol would not reduce the pregnancy rate of the patients.

Objective: To perform preimplantation genetic diagnosis (PGD) of chromosome abnormality using fluorescence in-situ hybridization (FISH)., Methods: Ten couples were presented for preimplantation genetic diagnosis. They had a total of 10 oocyte pick-up cycles. The collected oocytes were inseminated by intracytoplasmic sperm injection. PGD was carried out using cleavage-stage (day 3) embryo biopsy, fluorescence in-situ hybridization, and day 4 embryo transfer., Results: Ten oocyte pick-up cycles yielded 158 oocytes. Among the 94 embryos obtained, 54 embryos were biopsied and FISH analyses were performed for 51 blastomeres. Twenty-four embryos were transferred on the fourth day. There were 4 clinical pregnancies: 3 infants have been born, and 1 couple had ectopic pregnancy., Conclusion: PGD is a valuable method to prevent the high risk of spontaneous miscarriages and conceiving chromosomally unbalanced offspring.