Mild Stimulation Protocol Using Clomiphene Citrate for Women With PCOS Undergoing in Vitro Fertilization

What Was Tested

In this phase 4 trial, researchers set out to test HMG (Human Menopausal Gonadotropin) for pcos.

Ultrasound morphological features of PCOS include the presence of 16 or more follicles measuring 2-9 mm in diameter, and/or an overall large ovarian volume of \>10mm3.

It had two arms (groups): Group A (mild stimulation protocol) (experimental) and Group B (conventional stimulation protocol) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The prevalence of PCOS varies widely among different ethnic populations and is highest in the Middle East.

One way to diagnose PCOS is on the basis of the Rotterdam criteria, according to which women should satisfy 2 of 3 criteria including anovulation, polycystic ovarian morphology on ultrasound and hyperandrogenism (either clinical or biochemical).

Trans-vaginal ultrasound evaluation is an important tool to assess ovarian features and determine the risk for ovarian hyper-response to follicle stimulation.

Ultrasound morphological features of polycystic ovary syndrome (PCOS) include the presence of 16 or more follicles measuring 2-9mm in diameter, and/or an overall large ovarian volume of \>10mm3.

Who Took Part

The registry lists 154 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Female patients between 18-40 years of age. Antral follicle count exceeding 16 and/or AMH exceeding 3.5 ng/dl. PCOS features as per Rotterdam criteria: 2 of 3 criteria: a. Ultrasound morphology; b. Oligo/amenorrhea; c. Hyperandrogenism (clinical or chemical).

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: recurrent implantation failure; recurrent pregnancy loss; congenital uterine anomalies.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

Being open-label, the HMG (Human Menopausal Gonadotropin) study did not mask who received what.

It started in 2023-06-01 with completion listed for 2025-01-01.

It ran at 1 site in Lebanon.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Live birth rate (time frame: more than 24 weeks of gestation).

It also tracked 11 secondary outcomes, for example Total number of gonadotropins, Duration of stimulation, total number of developing follicles, Rate of GnRHa trigger of final follicle maturation, endometrial thickness and pattern, Fertilization rate and Cleavage rate.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of HMG (Human Menopausal Gonadotropin) in 154 people with pcos.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the HMG (Human Menopausal Gonadotropin) compound page, PCOS research.