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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Gasthuisberg
Sponsor:
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00492934
First received: June 26, 2007
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Infertility
Drug: human menopausal gonadotrophins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • implantation rate per embryo [ Time Frame: 15 days after the embryo transfer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • thickness of the endometrium [ Time Frame: 0-2 days before the human chorionic gonadotropin (hCG) injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2004
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Daily injections with a small dose of gonadotrophins from day 2 of the cycle
Drug: human menopausal gonadotrophins
Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation
Other Name: Menopur
No Intervention: 2
No daily injections with hormones

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492934

Contacts
Contact: Myriam Welkenhuysen, MSc 32 16 34 35 44 Myriam.Welkenhuysen@uzleuven.be

Locations
Belgium
Leuven University Fertility Center Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Myriam Welkenhuysen, MSc    32 16 34 35 44    Myriam.welkenhuysen@uzleuven.be   
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Study Director: Thomas D'Hooghe, MD, PhD University Hospital Gasthuisberg, Catholic University Leuven, Belgium
  More Information

No publications provided

Responsible Party: Thomas D'Hooghe, Professor, Medical Doctor, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00492934     History of Changes
Other Study ID Numbers: ML2436 - 30/12/2003
Study First Received: June 26, 2007
Last Updated: February 28, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
subfertility
endometrium thickness
implantation rate
embryo cryopreservation
embryo transfer

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014