Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Ninety women presenting with infertility were recruited from the outpatient clinic. Baseline data, including demographic and medical history, BMI, and laboratory investigations (CBC, renal and liver function tests, coagulation profile along with hormonal profile ), were collected. All patients underwent intracytoplasmic sperm injection for infertility.

Intracytoplasmic sperm injection

Intervention Type 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.

Interventions

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Intracytoplasmic sperm injection

• 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No