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

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ClinicalTrials.gov Identifier: NCT00492934
Recruitment Status : Unknown
Verified September 2014 by Thomas D'Hooghe, University Hospital, Gasthuisberg.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2007
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg

Tracking Information
First Submitted Date  ICMJE June 26, 2007
First Posted Date  ICMJE June 27, 2007
Last Update Posted Date September 10, 2014
Study Start Date  ICMJE January 2004
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2007)		 implantation rate per embryo [ Time Frame: 15 days after the embryo transfer ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)		 thickness of the endometrium [ Time Frame: 0-2 days before the human chorionic gonadotropin (hCG) injection ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2007)		 thickness of the endometrium [ Time Frame: 0-2 days before the hCG injection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?
Official Title  ICMJE Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: 1
    Daily injections with a small dose of gonadotrophins from day 2 of the cycle
    Intervention: Drug: human menopausal gonadotrophins
  • No Intervention: 2
    No daily injections with hormones
Publications * Peeraer K, Couck I, Debrock S, De Neubourg D, De Loecker P, Tomassetti C, Laenen A, Welkenhuysen M, Meeuwis L, Pelckmans S, Meuleman C, D'Hooghe T. Frozen-thawed embryo transfer in a natural or mildly hormonally stimulated cycle in women with regular ovulatory cycles: a RCT. Hum Reprod. 2015 Nov;30(11):2552-62. doi: 10.1093/humrep/dev224. Epub 2015 Sep 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 31, 2008)		 300
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2007)		 100
Estimated Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00492934
Other Study ID Numbers  ICMJE ML2436 - 30/12/2003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Thomas D'Hooghe, University Hospital, Gasthuisberg
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University Hospital, Gasthuisberg
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas D'Hooghe, MD, PhD University Hospital Gasthuisberg, Catholic University Leuven, Belgium
PRS Account University Hospital, Gasthuisberg
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP