What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?

Verified by: University Hospital, Gasthuisberg, June 2008
First Received: June 26, 2007 | Last Updated: October 9, 2008 | Phase: N/A | Start Date: January 2004
Overall Status: Recruiting | Estimated Enrollment: 300
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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...

Brief Summary

Official Title: “Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos”

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • 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

Secondary Measures

  • thickness of the endometrium
    • Time Frame: 0-2 days before the human chorionic gonadotropin (hCG) injection
      Safety Issue?: No

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 Investigator Information

Lead Investigator: University Hospital, Gasthuisberg Other

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 February 09, 2012

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

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