The study investigates if, among women with a regular cycle (between 25 and 45 days), the endometrium is better prepared for the transfer of an embryo that was cryopreserved and if the subsequent embryo implantation rate is higher when the cycle is started with daily, small-dose hormonal injections than in cycles without these daily injections...
Date First Received: June 26, 2007
Last Updated: October 9, 2008
Verified by: University Hospital, Gasthuisberg, June 2008
Clinical Trial Phase: N/A | Start Date: January 2004
Overall Status: Recruiting
Estimated Enrollment: 300
Brief Summary
Official Title: “Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos”
Condition Keyword(s):
Intervention(s):
The study investigates if, among women with a regular cycle (between 25 and 45 days), the endometrium is better prepared for the transfer of an embryo that was cryopreserved and if the subsequent embryo implantation rate is higher when the cycle is started with daily, small-dose hormonal injections than in cycles without these daily injections.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Study Primary Completion Date: December 2009
Intervention(s) in this Clinical Trial
- Drug: human menopausal gonadotrophins
- Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Daily injections with a small dose of gonadotrophins from day 2 of the cycle
- No Intervention: 2
- No daily injections with hormones
Outcome Measures for this Clinical Trial
Primary Measures
- implantation rate per embryo
- Time Frame: 15 days after the embryo transfer
Safety Issue?: No
- Time Frame: 15 days after the embryo transfer
Secondary Measures
- thickness of the endometrium
- Time Frame: 0-2 days before the human chorionic gonadotropin (hCG) injection
Safety Issue?: No
- Time Frame: 0-2 days before the human chorionic gonadotropin (hCG) injection
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Signed informed consent.
- Women with a regular cycle (between 21 and 35 days).
- Embryos with 50% intact blastomeres after thawing.
- Embryo and endometrium are synchronized.
Exclusion Criteria:
- Embryo storage time not longer than 5 years.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital, Gasthuisberg
Overall Clinical Trial Officials and Contacts
Thomas D'Hooghe, MD, PhD Study Director University Hospital Gasthuisberg, Catholic University Leuven, Belgium
Overall Contact: Myriam Welkenhuysen, MSc 32 16 34 35 44 Myriam.Welkenhuysen@uzleuven.be
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00492934
Study ID Number: ML2436 - 30/12/2003
ClinicalTrials.gov Identifier: NCT00492934
Health Authority: Belgium: Institutional Review Board
Clinical Trials Authorship and Review
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