Ovarian Morphology and Theca Cell Androgen Production in Women With Polycystic Ovary Syndrome (PCOS)

What Was Tested

This registered not phased trial tested hCG (human chorionic gonadotropin) for pcos.

Women with PCOS suffer from excess male hormone (androgen) production by the ovary.

Androgen is made by cells that surround follicles that contain eggs.

As the follicles (and eggs) grow and mature, there are more androgen producing cells.

It had two arms (groups): Normal adult women (active comparator) and Women with PCOS (active comparator).

The registry classes the interventions as drug.

More on the Plan

In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group.

As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgen.

The pattern of steroid hormone production revealed the predominant pathway by which androgens are generated in women with PCOS.

Inhibin B levels were similar between groups.

Who Took Part

The registry lists 39 actual participants took part.

It was open to women only aged from 18 years up to 37 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subjects will be determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound. Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start. Subjects will be determined to be normal controls if they have a clinical history of regular periods.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: women with hemoglobin less than 11 gm/dl at screening evaluation; women with untreated thyroid abnormalities; pregnant women or women who are nursing.

How the Study Was Run

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

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

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the pcos participants and staff both knew the treatment.

It started in 2014-05 with completion listed for 2017-02.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Percent Change of 17-OHP Levels From Baseline (time frame: before and 24 hours after adminisration of r-hCG).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of hCG (human chorionic gonadotropin) in 39 people with pcos.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the hCG (human chorionic gonadotropin) compound page, PCOS research.