- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07569315
Successive Doses of GnRH Agonist Versus Single Dose of GnRH Agonist to Trigger Ovulation in Hyper-responders
May 6, 2026 updated by: Bedaya Hospital
Successive Doses of GnRH Agonist Versus Single Dose of GnRH Agonist to Trigger Ovulation in Hyper-responders Undergoing IVF Cycle : A Randomized Controlled Study.
The aim of this randomized controlled study is to compare the efficacy of three successive doses of a GnRH agonist ( administered 36 , 24 and 12 hours before oocyte retrieval ) with a single dose of a GnRH agonist ( administered 36 hours before oocyte retrieval ) in triggering ovulation in hyper-responders
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
190
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Usama M. Fouda, Prof.
- Phone Number: +201095401375
- Email: umfrfouda@yahoo.com
Study Locations
-
-
-
Giza, Egypt
- Bedaya Hospital
-
Contact:
- Usama M. Fouda, Prof
- Email: umfrfouda@yahoo.com
-
Principal Investigator:
- Ahmed Gadallah
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-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- GnRH antagonist IVF cycle
- Hyper-responders to induction of ovulation
Exclusion Criteria:
- Hypogonadotrophic hypogonadism
- Endometriosis
- History of recurrent abortion
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Successive doses GnRH agonist
Three successive doses of GnRH agonist are administered 36 , 24 and 12 hours before oocyte retrieval
|
GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) is administered 36 hours before ovum pickup.
Two additional doses of triptorelin ( 0.1 mg / S.C ) are administered subcutaneously 12 and 24 hours after the first dose of GnRH agonist.
|
|
Active Comparator: Single dose GnRH agonist
A single dose of GnRH agonist is administered 36 hours before oocyte retrieval
|
GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) is administered 36 hours before ovum pickup.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metaphase-II oocytes rate
Time Frame: Ten to fifteen days after starting ovarian stimulation
|
Number of MII oocyte/ number of cumulus oocyte complex
|
Ten to fifteen days after starting ovarian stimulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical pregnancy rate
Time Frame: Five weeks after embryo transfer
|
Presence of intrauterine gestational sac detected by transvaginal ultrasound
|
Five weeks after embryo transfer
|
|
Ongoing pregnancy Rate
Time Frame: Eighteen weeks after embryo transfer
|
Pregnancies continued beyond 20 weeks gestation
|
Eighteen weeks after embryo transfer
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
April 29, 2026
First Submitted That Met QC Criteria
April 29, 2026
First Posted (Actual)
May 6, 2026
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Infertility
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Pituitary Hormone-Releasing Hormones
- Hypothalamic Hormones
- Peptide Hormones
- Neuropeptides
- Peptides
- Amino Acids, Peptides, and Proteins
- Oligopeptides
- Nerve Tissue Proteins
- Proteins
- Gonadotropin-Releasing Hormone
Other Study ID Numbers
- Successive/Single GnRH agonist
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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