Prospective, multicenter, randomized controlled trial towards identifying the optimal Cetrotide treatment protocol
Phase 4
Completed
- Conditions
- IVF/ICSI infertility10013356
- Registration Number
- NL-OMON37107
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2430
Inclusion Criteria
Women <=39 years with an indication for IVF or ICSI
Exclusion Criteria
More than 2 previous unsuccessful IVF/ICSI cycles
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the live birth rate per started cycle. Live birth from<br /><br>cryopreserved embryos originating from, and occurring within 6 months of the<br /><br>initial treatment cycle will be included in the total live birth rate per<br /><br>started cycle. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Ongoing, clinical and biochemical pregnancy rate<br /><br>Incidence of premature LH rise as detected on day of hCG administration<br /><br>LH, E2, P4 levels on CD2, CD6 and day of hCG administration<br /><br>Number of retrieved oocytes<br /><br>Total number of embryos available for transfer<br /><br>Number of embryos suitable for transfer<br /><br>Implantation rate per ET<br /><br>Endometrial thickness on ultrasound examination on day of oocyte pick-up<br /><br>QALY assessment</p><br>