Status:
UNKNOWN
New Application of Sequential in Vitro Muturation System for Infertility Patients With Polycystic Ovary Syndrome
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Hospital for Reproductive Medicine Affiliated to Shandong University
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Polycystic Ovary Syndrome
Infertility
Eligibility:
FEMALE
Up to 35 years
Phase:
PHASE3
Brief Summary
Oocyte in vitro maturation (IVM) is an artificial reproductive technologies (ART) in which cumulus-oocyte complex (COC) are collected at the immature germinal vesicle (GV) stage from unstimulated or F...
Detailed Description
A multi-center, prospective, randomized clinical trial will be conducted, of comparing sequential oocyte IVM system with traditional oocyte IVM system for high OHSS risk PCOS patients (AMH\>5.6ng/ml)....
Eligibility Criteria
Inclusion
- Women age ≤35 years;
- AMH level ≥5.6ng/ml;
- Women diagnosed as PCOS according to Chinese PCOS diagnosis criteria;
- Written informed consent.
Exclusion
- Women who diagnosed as uterus abnormality, adenomyosis, submucous myoma, intrauterine adhesion;
- Women who diagnosed as untreated hydrosalpinx;
- Women who had underwent unilateral ovariectomy;
- Women with medical condition that represent contraindication to assisted reproductive technology or pregnancy;
- Women or their partner with abnormal chromosome karyotype;
- Male partner with oligoasthenozoospermia or obstructive azoospermia;
- Male partner whose sperm is collected by surgery;
- Subjects are found breach the inclusion criteria, or in accordance with exclusion criteria during the test, excluded;
- Patients request withdrawal and exit the trial because adverse events occur during the trial.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03773263
Start Date
December 1 2018
End Date
March 1 2020
Last Update
December 12 2018
Active Locations (5)
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1
The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510610
2
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
3
Reproductive medical hospital affiliated to Shandong University
Jinan, Shandong, China, 250001
4
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000