Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection

Active, not recruiting

• Conditions: Infertility

• Registration Number: NCT06966219
• Lead Sponsor: Suez University

Brief Summary

Infertility is a condition affecting both female and male, characterized by the inability to conceive after 12 months or more of regular, unprotected sexual activity. All over the world, over 186 million people are affected by this condition, with the majority living in developing countries. In developing countries, the prevalence of infertility among women of reproductive age is estimated to affect one in every four couples. Type of the trigger during intracytoplasmic sperm injection might has impact on pregnancy rate.

Detailed Description

When 3rd generation Gonadotropin-releasing hormone antagonists (GnRH-a) were introduced in the 1990s for ovarian induction protocols, it became possible to trigger final oocyte maturation and ovulation with a single bolus of GnRH-a as an alternative to Human chorionic gonadotropin (HCG). Although some studies have suggested an increase in the percentage of mature 2 ((MII) oocytes retrieved with GnRH-a compared to HCG, it has been found that triggering ovulation with only GnRH agonist leads to a suboptimal luteal phase. The term "dual trigger" was first defined as the combination of a GnRH agonist and a low dose of HCG for triggering terminal oocyte maturation and avoid ovarian hyperstimulation syndrome (OHSS) in GnRH antagonist protocols.

Lin et al, conducted a retrospective study represent normal responders undergoing intracytoplasmic sperm injection )ICSI (with a GnRH antagonist trigger. They demonstratedsignificant improvements in the total number of retrieved oocytes, the number of mature (MII) oocytes, and rates of embryo implantation, clinical pregnancy, ongoing pregnancy, and live birth rate when the dual trigger protocol was used. Similarly, Lu et al. presented a retrospective analysis of fertility centers records where final oocyte maturation was triggered by either GnRH alone (Decapeptyl 0.1-0.2 mg) or in combination with HCG (1,000, 2,000, or 5,000 IU). They concluded that employing a dual trigger with a low dose of hCG (1,000 IU) as an adjunct to GnRH-a significantly improved the oocyte retrieval rate in suboptimal responders.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-01
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-10
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Patients are less than 38 years old

• Patients have primary or secondary infertility
• Patient is candidate for ICSI
• Normal antral follicles count
• AMH more than 1

Exclusion Criteria

• Age more than 38 years old
• Patients have other options for assisted reproductive techniques like
• intrauterine insemination.
• Severe male factor
• AMH less than 1
• Recurrent ICSI failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy rate after dual versus single trigger during ICSI	3 months

Trial Locations

Locations (1)

faculty of medicine, Suez university; 🇪🇬 Suez, Egypt