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Live Birth After Fresh Embryo Transfer Vs Frozen-thawed Embryo Transfer in Women With Polycystic Ovary Syndrome

Information source: Shandong University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovary Syndrome; Infertility

Intervention: fresh embryo transfer (Other); frozen-thawed embryo transfer (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Zi-jiang Chen

Official(s) and/or principal investigator(s):
Zi-jiang Chen, MD, Principal Investigator, Affiliation: Repreductive medical hospital affiliated to Shandong University

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: live birth rate

Secondary outcome:

Ovarian hyperstimulation syndrome (OHSS) incidence

clinical pregnancy rate

Pregnancy Loss rate

ectopic pregnancy rate

singleton live birth rate

pregnancy complication rate

Congenital Anomalies rate

neonatal complication rate

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.

Eligibility

Minimum age: 20 Years. Maximum age: 34 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- 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:

1. Ovulation dysfunction and failed to become pregnant from ovulation induction treatment; 2. Tubal factors: unilateral or bilateral tubal obstruction, adhesion, unilateral or bilateral Salpingectomy or tubal ligation; 3. 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.

Exclusion Criteria:

- 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.

Locations and Contacts

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, China

The First Affiliated Hospital of Lanzhou University, Lanzhou, Gansu 730000, China

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510120, China

The sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510655, China

Guangxi Maternal and Child Health Hospital, Nanning, Guangxi 530003, China

Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China

Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China

Jiangxi Maternal and Child Health Hospital, Nanchang, Jiangxi 330006, China

Reproductive Medicine Center in Shenyang City, Shenyang, Liaoning 110000, China

Reproductive medical hospital affiliated to Shandong University, Jinan, Shandong 250001, China

Yuhuangding Hospital in Yantai, Yantai, Shandong 264000, China

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai 200127, China

Shanxi Provincial Maternity and Children's Hospital, Xi'an, Shanxi 710003, China

Sir Run Run Shaw Hospital, Hangzhou, Zhejiang 310016, China

Additional Information

Related publications:

[1] Boomsma CM, Eijkemans MJ, Hughes EG, et al. A meta-analysis of pregnancy outcomes in women with polycystic ovary syndrome. Hum Reprod Update 12:673-83,2006. [2] Hayashi M, Nakai A, Satoh S, et al. Adverse obstetric and perinatal outcomes of singleton pregnancies may be related to maternal factors associated with infertility rather than the type of assisted reproductive technology procedure used. Fertil Steril 98:922-928,2012. [3] Chen XK, Wen SW, Bottomley J, et al. In vitro fertilization is associated with an increased risk for preeclampsia. Hypertens Pregnancy 28:1-12,2009. [4] Thomopoulos C, Tsioufis C, Michalopoulou H, et al. Assisted reproductive technology and pregnancy-related hypertensive complications: a systematic review. J Hum Hypertens 27:148-57,2013. [5] Haavaldsen C, Tanbo T, Eskild A. Placental weight in singleton pregnancies with and without assisted reproductive technology: a population study of 536,567 pregnancies. Hum Reprod 27:576-82,2012. [6] Maheshwari A, Pandey S, Shetty A, et al. Obstetric and perinatal outcomes in singleton pregnancies resulting from the transfer of frozen thawed versus fresh embryos generated through in vitro fertilization treatment: a systematic review and meta-analysis. Fertil Steril 98:368-77 e1-9,2012. [7] Kalra SK, Ratcliffe SJ, Coutifaris C, et al. Ovarian stimulation and low birth weight in newborns conceived through in vitro fertilization. Obstet Gynecol 118:863-871,2011.

Starting date: June 2013
Last updated: April 14, 2014

Page last updated: August 23, 2015

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