Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS

What Was Tested

The trial (phase 4) is built around hCG (human chorionic gonadotropin) for pcos.

It had two arms (groups): Clomiphene citrate-HCG group (active comparator) and Clomiphene citrate group (active comparator).

Women will receive clomiphene citrate and human chorionic gonadotropin (HCG).

Women will receive clomiphene citrate alone.

The registry classes the interventions as drug.

More on the Plan

Women will be randomly divided into two groups; CC-HCG group and CC group.

Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days.

If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory.

Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level.

Who Took Part

300 actual participants took part.

It was open to women only aged from 20 years up to 35 years.

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

Examples of who could join: Infertile lean women with PCOS as defined by the Rotterdam criteria.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: age \< 20 or \> 35 years; presence of any infertility factor other than anovulatory pcos; previous history of ovarian surgery or surgical removal of one ovary.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The pcos participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

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 2016-03 with completion listed for 2023-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Ovulation rate (time frame: 3 months).

It also tracked 4 secondary outcomes, for example Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation, Endometrial thickness on day of triggering of oocyte maturation, Clinical pregnancy rate and Incidence of early ovarian hyperstimulation syndrome (OHSS).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 300 people with pcos.

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, PCOS research.