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Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders

ConditionsICSIIVFNormal RespondersInfertility Assisted Reproductive TechnologyInfertile Women Undergoing IVF or ICSIInfertile Women Undergoing ARTTriggering OvulationOocyte Maturation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorAl-Azhar University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dual trigger (human chorionic gonadotropin plus GnRH-agonist)

    Drug

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

  • hCG trigger

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Dual TriggerExperimental treatment 1 intervention
Group B: HCG TriggerActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oocytes Maturation

Percentage of retrieved oocytes that are at the metaphase II (MII) stage.

Time frame
From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval.

Secondary outcomes

1

Number of MII oocytes

Number of metaphase II oocytes retrieved

Time frame
At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up.
2

Number of oocytes retrieved

Total number of oocytes retrieved during oocyte retrieval.

Time frame
Day of oocyte retrieval (Day 0) after oocyte retrieval.
3

Fertilization rate

Percentage of normally fertilized mature oocytes (2PN)

Time frame
Approximately 16-18 hours after insemination/ICSI
4

Embryo utilization rate

Percentage of normally fertilized oocytes resulting in embryos suitable for transfer or cryopreservation

Time frame
Day 3-5 after oocyte retrieval

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

International Islamic Center for Population Studies and Research

Collaborator

Source ClinicalTrials.gov
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