Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

faculty of medicine, Suez university

Suez, 43221, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracytoplasmic sperm injection

Other

All patients will commence controlled ovarian hyperstimulation (COH) on day 2 or 3 of their menstrual cycle. The initial treatment will be a daily administration of either highly purified human menopausal gonadotropin (hMG) or recombinant FSH (rFSH, Gonal-F 150 IU, Merck Serono, S.P.A, Italy) administered subcutaneously and intramuscularly for a duration of 10-12 days. The treatment will be continued until the final oocyte maturation. The starting dosage will be tailored based on the patient's age, antral follicle count (AFC), body mass index (BMI), serum FSH and AMH levels on days 2-3, as well as the patient's previous response to COH.

Primary outcomes

Pregnancy rate after dual versus single trigger during ICSI

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Suez University

Other

Registry information

Official study title

Impact of Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection: A Prospective Cohort Study

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: May 11, 2025
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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