What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?
Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 10, 2014
September 1, 2014
9.8 years
June 26, 2007
September 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
implantation rate per embryo
15 days after the embryo transfer
Secondary Outcomes (1)
thickness of the endometrium
0-2 days before the human chorionic gonadotropin (hCG) injection
Study Arms (2)
1
ACTIVE COMPARATORDaily injections with a small dose of gonadotrophins from day 2 of the cycle
2
NO INTERVENTIONNo daily injections with hormones
Interventions
Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Embryo storage time not longer than 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leuven University Fertility Center
Leuven, Vlaams Brabant, 3000, Belgium
Related Publications (1)
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.
PMID: 26364081DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas D'Hooghe, MD, PhD
University Hospital Gasthuisberg, Catholic University Leuven, Belgium
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Medical Doctor
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
January 1, 2004
Primary Completion
October 1, 2013
Study Completion
October 1, 2014
Last Updated
September 10, 2014
Record last verified: 2014-09