Vaginal Progesterone Supplementation in Women With PCOS Undergoing Ovulation Induction With Letrozole

What Was Tested

This registered phase 2, phase 3 trial tested hCG (human chorionic gonadotropin) for pcos.

It had two arms (groups): # 1- no progesterone therapy (other) and one (active comparator).

The registry classes the interventions as diagnostic test, drug and other.

More on the Plan

Approval of the study was obtained from the local IRB.

Prospective volunteers had had an infertility workup including blood hormone levels (FSH, LH, E2, Progesterone, Prolactin, and Thyroid), partner's semen analysis, HSG, laparoscopy or hydrosonogram, plus a baseline evaluation including ultrasound of ovaries and uterus performed as standard of care.

If the results of these tests and the remaining Inclusion/Exclusion criteria were met, the study consent was reviewed with participants and signatures were obtained.

Participants contacted the clinic at the start of their menses (spontaneous or progesterone-induced) to start the treatment cycle.

Who Took Part

52 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.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: untreated thyroid or prolactin abnormalities; pregnancy in the last 3 months; BMI\< 18 or \>40kg/m2.

How the Study Was Run

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

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

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

In this single-blind hCG (human chorionic gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2012-07-06 with completion listed for 2016-11-02.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Clinical pregnancy rates.

It also tracked 1 secondary outcome, for example Live birth rates.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of hCG (human chorionic gonadotropin) in 52 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.