Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders (DT-HCG-IVF)

October 5, 2026 updated by: Ahmed Mohamed Mohamed Gebreel, Al-Azhar University

Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders a Randomized Controlled Trial

To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles.

  • Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG.
  • hCG Trigger Group: Participants will receive hCG alone.

primary Outcomes

The following primary outcomes will be assessed:

• Number of mature (MII) oocytes (assessment at denudation). Secondary Outcomes

The following secondary outcomes will be assessed:

  • Number of retrieved oocytes.
  • Fertilization rate.
  • Number and quality of embryos.
  • Implantation rate.
  • Clinical pregnancy rate.
  • Multiple pregnancy rate.
  • Incidence of ovarian hyperstimulation syndrome (OHSS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Recruiting
        • ART Unit, International Islamic Center for Population Studies and Research, Al-Azhar University
        • Contact:
        • Principal Investigator:
          • Ahmed MM Gebreel, MSc.
        • Sub-Investigator:
          • Ehab HM Hasanin, Prof.
        • Sub-Investigator:
          • Mohamed S. Abdelall, Prof.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 20-40 years.
  • Body mass index (BMI) between 18 and 30 kg/m².
  • Undergoing ICSI treatment using a GnRH antagonist protocol.
  • Normal ovarian reserve and expected normal ovarian response.
  • AMH between 1.2 - 3.5 ng/ml
  • AFC 7-15 follicle.
  • First or second ICSI cycle.

Exclusion Criteria:

  • Poor ovarian response (Bologna/POSEIDON criteria)
  • High ovarian response with a risk of ovarian hyperstimulation syndrome (OHSS) AMH > 3.5 ng/ml or AFC > 15 follicle.
  • Polycystic ovary syndrome (PCOS).
  • Serum E2 level > 3500 pg/ml at day of triggering.
  • Endocrine disorders including diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, or Cushing syndrome.
  • Congenital uterine abnormalities.
  • Severe systemic diseases affecting fertility outcomes.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dual Trigger

Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG
Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist)

Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG for normal responders patients doing ICSI.

Other Names:
  • Triptorelin acetate and human chorionic gonadotropin
Active Comparator: HCG Trigger

HCGTrigger Group: Participants will receive hCG alone.
Drug: hCG trigger

hCG Trigger Group: Participants will receive hCG alone the standard for normal responders doing ICSI.

Other Names:
  • human chorionic gonadotropin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oocytes Maturation
Time Frame: From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval.

Percentage of retrieved oocytes that are at the metaphase II (MII) stage.
From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of MII oocytes
Time Frame: At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up.

Number of metaphase II oocytes retrieved
At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up.
Number of oocytes retrieved
Time Frame: Day of oocyte retrieval (Day 0) after oocyte retrieval.

Total number of oocytes retrieved during oocyte retrieval.
Day of oocyte retrieval (Day 0) after oocyte retrieval.
Fertilization rate
Time Frame: Approximately 16-18 hours after insemination/ICSI

Percentage of normally fertilized mature oocytes (2PN)
Approximately 16-18 hours after insemination/ICSI
Embryo utilization rate
Time Frame: Day 3-5 after oocyte retrieval

Percentage of normally fertilized oocytes resulting in embryos suitable for transfer or cryopreservation
Day 3-5 after oocyte retrieval
Clinical pregnancy rate
Time Frame: Approximately 5-7 weeks after embryo transfer

Percentage of embryo transfer cycles resulting in an intrauterine gestational sac with fetal cardiac activity
Approximately 5-7 weeks after embryo transfer
Incidence of ovarian hyperstimulation syndrome (OHSS)
Time Frame: From the day of trigger administration until 14 days after oocyte retrieval

Proportion of participants developing OHSS following controlled ovarian stimulation and oocyte retrieval, classified according to predefined diagnostic/severity criteria.
From the day of trigger administration until 14 days after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Azhar University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
International Islamic Center for Population Studies and Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ehab HM Hasanin, Professor, Obstetrics and Gynecology Department, Al-Azhar University.
  • Study Director: Mohamed S. Abdelall, Professor, International Islamic Center for Population Studies and Research

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.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Obs-Gyn-1000/2026/07/0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

raw data and master sheet can be shared

IPD Sharing Time Frame

After completion of study will be available for one year

IPD Sharing Access Criteria

request by email agebreel@hotmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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