Study Stopped
The investigators were not able to get grant funding for this study.
GnRH Agonist at Embryo Transfer: IVF Outcomes
GRAET
Does a GnRH Agonist Given at Embryo Transfer Improve Clinical Pregnancy and Live Birth Rates of Women Undergoing In-Vitro Fertilization?
1 other identifier
interventional
N/A
1 country
1
Brief Summary
In ART (assisted reproductive technology) cycles, embryos are transferred to a woman's uterus after in-vitro fertilization (IVF) in a laboratory. Usually, hormones (progesterone) are given to the patient after transferring the embryo, as a supplement, in order to mimic the natural hormones that would normally be secreted in an unassisted pregnancy. This study will identify whether additional gonadotropin-releasing hormone (GnRH-agonist) administration, a natural hormone secreted from the hypothalamus, will improve the clinical pregnancy and live birth rates when using IVF.
Trial Health
Trial Health Score
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Started Apr 2019
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedStudy Start
First participant enrolled
April 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedApril 16, 2019
April 1, 2019
1.2 years
May 21, 2018
April 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rate
Percentage of live births for all patients included.
2 years
Secondary Outcomes (2)
Miscarriage rate
2 years
Clinical pregnancy rate
2 years
Study Arms (2)
Saline Solution for Injection
PLACEBO COMPARATORThis arm will receive a one-time subcutaneous injection of 0.4mL normal saline solution at the time of embryo transfer. This arm will continue to receive all the same treatments that everyone routinely receives for the IVF cycle, e.g. estrogen and progesterone supplements.
Leuprolide Acetate
EXPERIMENTALThis arm will receive a one-time subcutaneous injection of 0.4U (0.2mg=0.4mL) Leuprolide acetate at the time of embryo transfer. This arm will continue to receive all the same routine treatments for the IVF cycle, e.g. estrogen and progesterone supplements.
Interventions
Placebo arm will receive a saline injection
Treatment arm will receive a Leuprolide injection
Eligibility Criteria
You may qualify if:
- Women undergoing in-vitro fertilization who are receiving an embryo transfer of a day 5 blastocyst
You may not qualify if:
- Those who have a contraindication to receiving the medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Genesis Fertility Center
Brooklyn, New York, 11204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antonios Likourezos, M.P.H., M.A.
Maimonides Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Patient and provider will both be blinded to the medication that the patient receives.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2018
First Posted
June 1, 2018
Study Start
April 15, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2021
Last Updated
April 16, 2019
Record last verified: 2019-04