Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction

NCT ID: NCT06725004

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-06-30

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

Detailed Description

This is an open label randomized controlled trial. After baseline transvaginal sonography (TVS), all the participants will be given tablet letrozole 5 mg or more from day 2 to day 6 of their menstrual cycle. Then participants will be followed up by TVS for follicular maturation and endometrial thickness.When the size of mature follicle will be at least 18mm , then participants will be randomized into experimental group and comparator group. The participants in experimental group will receive inj. (injection) oxytocin 10 IU (Inj. Linda 10 unit, Nuvista Pharmaceuticals Limited) intramuscular as trigger and the participants in control group received Inj. hCG 5000 IU (Inj. hCG 5000 IU, Popular Pharmaceuticals Limited) intramuscular as trigger. Participants will be followed up 36 hours after injection by TVS for follicular rupture. On the 7th day following oxytocin or hCG injection, serum progesterone level will be measured by chemiluminescent immunoassay . Participants will be followed until the next cycle for conception. If conception does not occur, then the procedure will be repeated in next cycle for 3 cycles.

Random sequence generation will be done by computer generated random numbers after permuted block randomization. Allocation concealment will be done by serially numbered closed envelops. Each envelop will be labeled with a serial number and has a card inside noting the intervention drug. A sample size of 24 in each group will be calculated to detect a non-inferiority margin difference between the group proportions with 80.9% power and the level of significance 0.05. Considering 10% patients drop out, 30 participants will be recruited in each group.

Conditions

Ovulation Induction; Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxytocin

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

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Injection Oxytocin 10 mg intramuscular as trigger for ovulation induction

Human Chorionic Gonadotropin

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

Group Type: ACTIVE_COMPARATOR

Human Chorionic Gonadotropin

Intervention Type: DRUG

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

Interventions

Oxytocin

Injection Oxytocin 10 mg intramuscular as trigger for ovulation induction

Intervention Type: DRUG

Human Chorionic Gonadotropin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shakeela Ishrat

OTHER

Sponsor Role: lead

Responsible Party

Shakeela Ishrat

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shakeela Ishrat, FCPS,MS

Role: STUDY_DIRECTOR

Bangladesh Medical University

Locations

Bangabandhu Sheikh Mujib Medical University

Dhaka, Dhaka Division, Bangladesh

Countries

Bangladesh

References

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.

Reference Type: BACKGROUND

PMID: 24359041 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24482059 (View on PubMed)

Other Identifiers

4221

Identifier Type: -

Identifier Source: org_study_id