Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection

NCT06966219 | Active Not Recruiting DMC

• 1 other identifier: 3
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

icsi; dual trigger

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate after dual versus single trigger during ICSI

  3 months

Study Arms (1)

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.

Other: Intracytoplasmic sperm injection

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

females attended the clinic with a history of infertility required Intracytoplasmic sperm inaction

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez University: lead

Study Sites (1)

faculty of medicine, Suez university

Suez, 43221, Egypt

Location

Related Publications (5)

• 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.

  PMID: 23993928 BACKGROUND

• 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.

  PMID: 17981269 BACKGROUND

• 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.

  PMID: 1601147 BACKGROUND

• 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.

  PMID: 21377153 BACKGROUND

• 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.

  PMID: 23271957 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Wessam aboelghar

  faculty of medicine, Suez university Suez, Suez, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: May 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)