Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction

What Was Tested

This registered phase 3 trial tested hCG (human chorionic gonadotropin) and Oxytocin.

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?

It had two arms (groups): Oxytocin (experimental) and Human Chorionic Gonadotropin (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is an open label randomized controlled trial.

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.

Participants will be followed up 36 hours after injection by TVS for follicular rupture.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: male factor abnormality; bilateral tubal block; any pelvic pathology like pelvic inflammatory diseases.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-01-01 with completion listed for 2023-12-31.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of participants having ovulation (time frame: 1 week).

It also tracked 1 secondary outcome, for example Number of participants having pregnancy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) and Oxytocin in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page and the Oxytocin compound page, all human trials.