Status:
UNKNOWN
Live Birth After Fresh Embryo Transfer Vs Frozen-thawed Embryo Transfer in Women With Polycystic Ovary Syndrome
Lead Sponsor:
Zi-jiang Chen
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Polycystic Ovary Syndrome
Infertility
Eligibility:
FEMALE
20-34 years
Phase:
NA
Brief 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 controver...
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) antagoni...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
1180 Patients enrolled
Trial Details
Trial ID
NCT01841528
Start Date
June 1 2013
End Date
June 1 2015
Last Update
April 16 2014
Active Locations (14)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
2
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
4
The sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510655