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) incidenceclinical 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
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