A randomised controlled trial comparing in vitro maturation of oocytes with in vitro fertilisation in women with an increased risk of ovarian hyperstimulation syndrome.
Recruiting
- Conditions
- Infertility, PCOS, OHSS
- Registration Number
- NL-OMON24086
- Lead Sponsor
- Jeroen Bosch Hospital
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
1. Women with PCOS according to the Rotterdam Criteria (The Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group, 2004) which not did achieve an ongoing pregnancy after ovulation induction (with clomiphene citrate or LEO and rFSH);
2. Women with an IVF or ICSI indication and increased risk for developing OHSS (history of OHSS or cycle cancellation for imminent OHSS).
Exclusion Criteria
1. Woman or partner younger than 18 years and woman older than 38 years;
2. Unable to speak or read the Dutch language;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative live birth rate after IVM/ICSI or COH/IVF/ICSI strategy including pregnancies from cryoembryos transferred within 12 months after the end of IVM/ICSI or COH/IVF/ICSI treatment.
- Secondary Outcome Measures
Name Time Method 1. Health and development of IVM/ICSI children versus COH/IVF/ICSI children in a 5 years’ follow up program;<br /><br>2. Number and nature of adverse events during or following the two treatment strategies, specifically including OHSS and multiple pregnancies;<br /><br>3. Direct and indirect costs of the two treatment strategies;<br /><br>4. Patients’ quality of life scores as derived from validated questionnaires.