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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

20 Years
34 Years
Not Enrolling
Polycystic Ovary Syndrome, Infertility

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Trial Information

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.

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

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

- Women or their partner with abnormal chromosome karyotype including chromosome

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

live birth rate

Outcome Description:

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.

Outcome Time Frame:

10 months for group A, 12 months for group B

Safety Issue:


Principal Investigator

Zi-jiang Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Repreductive medical hospital affiliated to Shandong University


China: Ministry of Health

Study ID:




Start Date:

May 2013

Completion Date:

May 2015

Related Keywords:

  • Polycystic Ovary Syndrome
  • Infertility
  • Polycystic Ovary Syndrome
  • Infertility
  • In-vitro fertilization
  • fresh embryo transfer
  • frozen-thawed embryo transfer
  • Infertility
  • Polycystic Ovary Syndrome