Clinical trial NCT06966219: Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection
Official title: Impact of Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Infertility
Keywords: icsi
dual trigger
Lead sponsor: Suez University
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females attended the clinic with a history of infertility required Intracytoplasmic sperm inaction

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy rate after dual versus single trigger during ICSI
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suez
country: Egypt
facility: faculty of medicine, Suez university
Study officials:
affiliation: faculty of medicine, Suez university Suez, Suez, Egypt
name: Wessam aboelghar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin MH, Wu FS, Lee RK, Li SH, Lin SY, Hwu YM. Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles. Fertil Steril. 2013 Nov;100(5):1296-302. doi: 10.1016/j.fertnstert.2013.07.1976. Epub 2013 Aug 28.
citation: Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Thomas S. Gonadotropin-releasing hormone agonist combined with a reduced dose of human chorionic gonadotropin for final oocyte maturation in fresh autologous cycles of in vitro fertilization. Fertil Steril. 2008 Jul;90(1):231-3. doi: 10.1016/j.fertnstert.2007.06.030. Epub 2007 Nov 5.
citation: Segal S, Casper RF. Gonadotropin-releasing hormone agonist versus human chorionic gonadotropin for triggering follicular maturation in in vitro fertilization. Fertil Steril. 1992 Jun;57(6):1254-8.
citation: Humaidan P, Westergaard LG, Mikkelsen AL, Fukuda M, Yding Andersen C. Levels of the epidermal growth factor-like peptide amphiregulin in follicular fluid reflect the mode of triggering ovulation: a comparison between gonadotrophin-releasing hormone agonist and urinary human chorionic gonadotrophin. Fertil Steril. 2011 May;95(6):2034-8. doi: 10.1016/j.fertnstert.2011.02.013. Epub 2011 Mar 5.
citation: Mascarenhas MN, Flaxman SR, Boerma T, Vanderpoel S, Stevens GA. National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys. PLoS Med. 2012;9(12):e1001356. doi: 10.1371/journal.pmed.1001356. Epub 2012 Dec 18.