Back to resultsWhat is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
human menopausal gonadotrophins
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring subfertility, endometrium thickness, implantation rate, embryo cryopreservation, embryo transfer
Eligibility 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.
Sites / Locations
- Leuven University Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
Daily injections with a small dose of gonadotrophins from day 2 of the cycle
No daily injections with hormones
Outcomes
Primary Outcome Measures
implantation rate per embryo
Secondary Outcome Measures
thickness of the endometrium
Full Information
NCT ID
NCT00492934
First Posted
June 26, 2007
Last Updated
September 9, 2014
Sponsor
University Hospital, Gasthuisberg
1. Study Identification
Unique Protocol Identification Number
NCT00492934
Brief Title
What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?
Official Title
Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gasthuisberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
subfertility, endometrium thickness, implantation rate, embryo cryopreservation, embryo transfer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Daily injections with a small dose of gonadotrophins from day 2 of the cycle
Arm Title
2
Arm Type
No Intervention
Arm Description
No daily injections with hormones
Intervention Type
Drug
Intervention Name(s)
human menopausal gonadotrophins
Other Intervention Name(s)
Menopur
Intervention Description
Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation
Primary Outcome Measure Information:
Title
implantation rate per embryo
Time Frame
15 days after the embryo transfer
Secondary Outcome Measure Information:
Title
thickness of the endometrium
Time Frame
0-2 days before the human chorionic gonadotropin (hCG) injection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas D'Hooghe, MD, PhD
Organizational Affiliation
University Hospital Gasthuisberg, Catholic University Leuven, Belgium
Official's Role
Study Director
Facility Information:
Facility Name
Leuven University Fertility Center
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
26364081
Citation
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.
Results Reference
derived
Learn more about this trial
What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?
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