- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00492934
What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?
September 9, 2014 updated by: Thomas D'Hooghe, University Hospital, Gasthuisberg
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vlaams Brabant
-
Leuven, Vlaams Brabant, Belgium, 3000
- Leuven University Fertility Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Daily injections with a small dose of gonadotrophins from day 2 of the cycle
|
Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation
Other Names:
|
No Intervention: 2
No daily injections with hormones
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
implantation rate per embryo
Time Frame: 15 days after the embryo transfer
|
15 days after the embryo transfer
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
thickness of the endometrium
Time Frame: 0-2 days before the human chorionic gonadotropin (hCG) injection
|
0-2 days before the human chorionic gonadotropin (hCG) injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Thomas D'Hooghe, MD, PhD, University Hospital Gasthuisberg, Catholic University Leuven, Belgium
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
October 1, 2013
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
June 26, 2007
First Submitted That Met QC Criteria
June 26, 2007
First Posted (Estimate)
June 27, 2007
Study Record Updates
Last Update Posted (Estimate)
September 10, 2014
Last Update Submitted That Met QC Criteria
September 9, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML2436 - 30/12/2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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