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

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

Study Locations

    • Giza Governorate
      • Giza, Giza Governorate, Egypt, 3753303
        • Bedaya Hospital
        • Contact:
        • 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

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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