The Effect of Oxytocin (OT) and Oxytocin Plus Human Chorionic Gonadotropin (hCG), in Cycles Induced by Letrozole or Clomiphene Citrate

What Was Tested

In this phase 2 trial, researchers set out to test hCG (human chorionic gonadotropin) and Oxytocin.

It had five arms (groups): letrozole+hCG (no intervention), letrozole+oxytocin (no intervention), letrozole+oxytocin+hCG (no intervention), clomiphene citrate +oxytocin (no intervention) and clomiphene citrate +oxytocin+hCG (no intervention).

The registry classes the interventions as drug.

More on the Plan

In a randomized controlled prospective clinical study, a total of 177 infertile women with CC+hCG-resistant PCOS included.

Infertile women who had chronic anovulation and classical PCOS with CC+hCG failure were age \<40 y , had patent tubes on hysterosalpingography, and no other pelvic pathology, participated in this study.

The patients who had hypersensivity to any oxytocic medications, history of cardiovascular disease, and took anti-hypertensive medications were excluded.

In addition, women with blood pressure less than 90/60 mmHg, abnormal spermogram, anxiety, excess prolactin levels, and other causes of infertility were excluded.

Who Took Part

Enrollment: 177 actual participants took part.

It was open to women only aged from 17 years up to 40 years.

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

Examples of who could join: Infertile women who had chronic anovulation. Classical PCOS with CC+hCG failure. Age \<40 y. Had patent tubes on hysterosalpingography. No other pelvic pathology.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: hypersensitivity to any oxytocic medications; history of cardiovascular disease; took anti-hypertensive medications were excluded.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2006-10 with completion listed for 2007-09.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: number of follicles, endometrial thickness, and clinical pregnancy rate (time frame: first ,second and third month).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of hCG (human chorionic gonadotropin) and Oxytocin in 177 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.