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Brief Title: Live Birth After Fresh Embryo Transfer Vs Frozen-thawed Embryo Transfer in Women With Polycystic Ovary Syndrome
Official Title: Live Birth After Fresh Embryo Transfer vs Elective Embryo Cryopreservation/Frozen Embryo Transfer in Women With Polycystic Ovary Syndrome Undergoing IVF: A Multi-center Prospective Randomized Clinical Trial
Study ID: NCT01841528
Brief Summary: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of childbearing age. However, the optimal infertility treatment for PCOS patients is still a matter of controversy. Despite producing more follicles and more oocytes than other women undergoing controlled ovarian hyperstimulation during an IVF cycle, women with PCOS have comparable or lower pregnancy rates. Additionally women with PCOS patients undergoing IVF have a higher risk of developing ovarian hyperstimulation syndrome (OHSS), which may be aggravated by pregnancy after an embryo transfer in a fresh cycle. Further women with PCOS are thought to have higher rates of later pregnancy complications including spontaneous abortion, pre-eclampsia, and preterm labor that may be related to impaired implantation in the superovulated endometrium. We propose a randomized clinical trial of elective embryo cryopreservation followed by a programmed cycle of endometrial preparation and frozen embryo transfer (FET) compared to fresh embryo transfer in women with PCOS undergoing in vitro fertilization (IVF).
Detailed Description: This will be a multi-center, prospective, randomized (1:1 ratio)clinical trial of frozen-thawed embryo transfer vs. fresh embryo transfer after a uniform gonadotropin-releasing hormone (GnRH) antagonist protocol in infertile PCOS patients receiving IVF therapy. Qualified 1180 patients are randomized into either of two groups: group A will undergo fresh embryo transfer (590 cases), Group B will undergo elective cryopreservation of all embryos followed by transfer of thawed embryos to a programmed endometrium (590 cases). All of the participants will receive recombinant follicule stimulating hormone (rFSH)/GnRH antagonist protocol for ovarian stimulation and standardized luteal phase support. The target population will be infertile PCOS patients aged between 20 and 35 years, diagnosed by the Chinese PCOS Criteria(i.e. menstrual disorders PLUS either one of the remaining two criteria, hyperandrogenism or polycystic ovaries on ultrasound, with exclusion of secondary causes of hyperandrogenism and ovulation dysfunction). And subjects will be those who are undergoing their first IVF or intracytoplasmatic sperm injection (ICSI) cycle without other known factors interfere reproductive or metabolic functions. The randomization will take place at the oocyte pick-up day by an on-line randomization system. The pregnancy test results, pregnancy complications, congenital anomalies neonatal complications will be followed up by checking medical records and telephone calls.
Minimum Age: 20 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
The First Affiliated Hospital of Lanzhou University, Lanzhou, Gansu, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China
The sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China
Guangxi Maternal and Child Health Hospital, Nanning, Guangxi, China
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital, Nanchang, Jiangxi, China
Reproductive Medicine Center in Shenyang City, Shenyang, Liaoning, China
Reproductive medical hospital affiliated to Shandong University, Jinan, Shandong, China
Yuhuangding Hospital in Yantai, Yantai, Shandong, China
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Shanxi Provincial Maternity and Children's Hospital, Xi'an, Shanxi, China
Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China
Name: Zi-jiang Chen, MD
Affiliation: Repreductive medical hospital affiliated to Shandong University
Role: PRINCIPAL_INVESTIGATOR