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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,180
- 试验地点
- 14
- 主要终点
- live birth rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed as PCOS according to Chinese PCOS diagnosis criteria;
- •Women who have ≥1 years history of infertility;
- •Women aged ≥20 and <35 years old;
- •Women with body weight ≥40kg;
- •Women who have at least one of the following indications for IVF or ICSI:
- •Ovulation dysfunction and failed to become pregnant from ovulation induction treatment;
- •Tubal factors: unilateral or bilateral tubal obstruction, adhesion, unilateral or bilateral Salpingectomy or tubal ligation;
- •Male factors: oligoasthenozoospermia, obstructive azoospermia;
- •Women who are undergoing their first cycle of IVF or ICSI;
- •Women who retrieved oocytes number > 3;
- •Women who are capable of giving informed consent.
排除标准
- •Women who underwent unilateral ovariectomy;
- •Women diagnosed as uterus abnormality: malformed uterus (uterus unicorns, septate uterus, duplex uterus, uterus bicomis), adenomyosis, submucous myoma, intrauterine adhesion;
- •Women or their partner with abnormal chromosome karyotype including chromosome polymorphism;
- •Women who have experienced recurrent spontaneous abortion (including biochemical pregnancy abortion) more than 2 times;
- •Women with medical condition that represent contraindication to assisted reproductive technology and/or pregnancy;
- •Women who has developed severe OHSS before oocyte pick-up day;
- •Women with retrieved oocytes number ≤3;
- •Women who are unable to comply with the study procedures.
研究组 & 干预措施
fresh embryo transfer group
rFSH/GnRH antagonist will be administered for ovarian stimulation. Two fresh embryos will be transferred at Day 3. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum human chorionic gonadotropin (HCG) will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
干预措施: fresh embryo transfer (Other)
frozen-thawed embryo transfer group
rFSH/GnRH antagonist will be administered for ovarian stimulation. All embryos will be vitrified in fresh cycle, and at least 2 embryos should be frozen at Day 3. Two months later, two thawed Day 3 embryos will be transferred with hormone replacement therapy (HRT) prepared endometrium. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum human chorionic gonadotropin (HCG) will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
干预措施: frozen-thawed embryo transfer (Other)
结局指标
主要结局
live birth rate
时间窗: 10 months for group A, 12 months for group B
This will be based on the outcome of either the fresh embryo transfer after ovarian stimulation (Group A) or the outcome of the first frozen embryo transfer cycle (Group B) as will all other secondary outcomes.
次要结局
- Ovarian hyperstimulation syndrome (OHSS) incidence(2 months in maximum estimated)
- clinical pregnancy rate(35 days after embryo transfer)
- Pregnancy Loss rate(28 weeks gestation in maximum)
- ectopic pregnancy rate(7~8 weeks gestation)
- singleton live birth rate(10 months for group A, 12 months for group B)
- neonatal complication rate(within one month after labor)
- pregnancy complication rate(10 months for group A, 12 months for group B)
- Congenital Anomalies rate(10 months for group A, 12 months for group B)
研究者
Zi-jiang Chen
Director of Reproductive medical center of Shandong University
Shandong University