Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin).

It had two arms (groups): one (experimental) and Clomiphen citrate plus HMG (active comparator).

The registry classes the interventions as drug.

More on the Plan

All subjects will be given the written informed consent.

In both experimental groups HCG administration will be continued until the largest follicle is 18-20 mm.

Ultrasound measurements of follicle number and growth, ovulation, gestational sac, and serum hormonal levels will be recorded and compared between two groups.

Who Took Part

The registry lists 10 actual participants took part.

It was open to women only aged from 18 years up to 30 years.

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

Examples of who could join: Women with PCOS diagnosed by the Rotterdam criteria. Documented normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy;. Male partner had to have a normal semen analysis by World Health Organization criteria.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: previous history of ivf or icsi treatments; history of hormonal treatment within recent three month (except ocp, progesterone); history of ovarian cutter or ovarian drilling.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received hCG (human chorionic gonadotropin).

Those kept unaware of assignments: participant and investigator.

It started in 2009-08 with completion listed for 2010-08.

It ran at 1 site in Iran.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Multiple pregnancy rates, OHSS rate (time frame: Within 20 months after recruiting).

It also tracked 4 secondary outcomes, for example Pregnancy rate, The number of embryos available for transfer and The embryo implantation rate and The live birth rate.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin) in 10 people.

Its size is small, so on its own it can only give an early look.

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 HMG (Human Menopausal Gonadotropin) compound page, all human trials.