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NCT Number: NCT06725004

Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction

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

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Key information

Conditions

Ovulation Induction Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, Dhaka Division, 1200, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Injection Oxytocin 10 mg intramuscular as trigger for ovulation induction

Human Chorionic Gonadotropin

Drug

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

Primary outcomes

  1. Number of participants having ovulation

    Time frame: 1 week

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

Secondary outcomes

  1. Number of participants having pregnancy

    Time frame: 3 weeks

    Number of participants having pregnancy determined by urinary pregnancy kit test after missed period.

Sponsors and collaborators

Lead sponsor

Shakeela Ishrat

Other

Registry information

Official study title

Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction Cycles: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 9, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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