- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07569302
Triggering Ovulation in Normo-responders Using a Modified Dual Trigger Protocol or HCG Trigger
April 29, 2026 updated by: Bedaya Hospital
Triggering Ovulation in Normo-responders Using a Modified Dual Trigger Protocol or HCG Trigger . A Randomized Controlled Study
The aim of this randomized controlled study is to compare the efficacy of a modified dual trigger protocol [a single bolos of HCG combined with two successive doses of a GnRH agonist ] with HCG [a single bolos administered 36 hours before oocyte retrieval ] in triggering ovulation in normo-responders undergoing ovarian stimulation using the antagonist protocol.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
196
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 Governorate
-
Giza, Giza Governorate, Egypt, 3753303
- Bedaya Hospital
-
Contact:
- Usama M Fouda, Prof
- Phone Number: +201095401375
- Email: umfrfouda@yahoo.com
-
Principal Investigator:
- Amira Alasmar, M.D, PhD
-
-
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
- Normo-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: Modified dual trigger group
HCG is administered 36 hours before ovum pickup and two successive doses of GnRH are administered 36 and 24 hours before ovum pickup.
|
HCG (10000 IU /IM) and triptorelin (0.2 mg/S.C) are administered 36 hours before ovum pickup .
Moreover, 0.1mg of triptorelin is administered 24 h prior to ovum pick-up.
|
|
Active Comparator: HCG group
A single dose of HCG is administered 36 hours before oocyte retrieval
|
HCG (10000 IU/IM ) 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
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 6, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dual trigger/normo-responders
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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