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
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
The pregnancy test results, pregnancy complications, congenital anomalies neonatal
complications will be followed up by checking medical records and telephone calls.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
live birth rate
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.
10 months for group A, 12 months for group B
Zi-jiang Chen, MD
Repreductive medical hospital affiliated to Shandong University
China: Ministry of Health