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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Drug: human menopausal gonadotrophins Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos
Study Start Date : January 2004
Actual Primary Completion Date : October 2013
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Menotropins

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. implantation rate per embryo [ Time Frame: 15 days after the embryo transfer ]

Secondary Outcome Measures :
  1. thickness of the endometrium [ Time Frame: 0-2 days before the human chorionic gonadotropin (hCG) injection ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492934


Locations
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Belgium
Leuven University Fertility Center
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
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Study Director: Thomas D'Hooghe, MD, PhD University Hospital Gasthuisberg, Catholic University Leuven, Belgium
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas D'Hooghe, Professor, Medical Doctor, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00492934    
Other Study ID Numbers: ML2436 - 30/12/2003
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Keywords provided by Thomas D'Hooghe, University Hospital, Gasthuisberg:
subfertility
endometrium thickness
implantation rate
embryo cryopreservation
embryo transfer
Additional relevant MeSH terms:
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Infertility
Genital Diseases
Urogenital Diseases
Menotropins
 Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs