Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction

NCT06725004 | Completed Phase 3

• 1 other identifier: 4221
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if injection oxytocin can be used as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome. The main questions it aims to answer are:

• Does injection oxytocin have similar ovulation rate as injection human chorionic gonadotropin (hCG) when used as trigger?
• Does injection oxytocin have similar pregnancy rate as injection human chorionic gonadotropin (hCG) when used as trigger? Researchers will compare injection oxytocin to injection hCG to see if injection oxytocin is as effective as injection hCG as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome. Participants will
• Take injection oxytocin or injection hCG as trigger over three subsequent ovulation induction cycles
• Be checked for ovulation by follicular rupture in TVS after 36 hours or raised serum progesterone level on day 7 after trigger
• Be checked for pregnancy by urine pregnancy test kit after missed period

Conditions

Ovulation Induction; Polycystic Ovary Syndrome

Keywords

Ovulation induction; Polycystic Ovary Syndrome; Oxytocin; Human Chorionic Gonadotropin (HCG)

Outcome Measures

Primary Outcomes (1)

• Number of participants having ovulation

  Number of participants having ovulation defined by findings on TVS after 36 hours and/or serum progesterone level 7th day after triggering

  1 week

Secondary Outcomes (1)

• Number of participants having pregnancy

  3 weeks

Study Arms (2)

Oxytocin

EXPERIMENTAL

Participants will receive injection oxytocin 10 mg intramuscular as trigger for ovulation induction

Drug: Oxytocin

Human Chorionic Gonadotropin

ACTIVE COMPARATOR

Participants will receive injection Human Chorionic Gonadotropin 5000 IU intramuscular as trigger for ovulation induction

Drug: Human Chorionic Gonadotropin

Interventions

Oxytocin DRUG

Injection Oxytocin 10 mg intramuscular as trigger for ovulation induction

Oxytocin

Human Chorionic Gonadotropin DRUG

Injection Human Chorionic Gonadotropin 5000 IU intramuscular as trigger for ovulation induction

Human Chorionic Gonadotropin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile women with polycystic ovary syndrome
• Age less than 40 years
• Had ovulation induction with letrozole, with at least one mature follicle detected on folliculometry

You may not qualify if:

• Male factor abnormality
• Bilateral tubal block
• Any pelvic pathology like pelvic inflammatory diseases
• Any uterine abnormality
• Ovarian cysts
• Any cardiovascular diseases or other systemic diseases
• Hyperprolactinemia or thyroid dysfunction
• Any drugs that affect the functions of hypothalamus, pituitary gland, and gonads
• Any known hypersensitivity to oxytocin

Sponsors & Collaborators

• Shakeela Ishrat: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Dhaka Division, 1200, Bangladesh

Location

Related Publications (2)

• Mehrotra S, Singh U, Gupta HP, Tandon I, Saxena P. A prospective double blind study comparing the effects of oxytocin and human chorionic gonadotrophin as trigger for ovulation. J Obstet Gynaecol. 2014 Jan;34(1):13-6. doi: 10.3109/01443615.2013.822479.

  PMID: 24359041 BACKGROUND

• George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.

  PMID: 24482059 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Oxytocin; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Gonadotropins; Placental Hormones; Pregnancy Proteins; Proteins

Study Officials

• Shakeela Ishrat, FCPS,MS

  Bangladesh Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)