Dysregulation of FSH in Obesity: Functional and Statistical Analysis

What Was Tested

In this not phased trial, researchers set out to test Cetrorelix and Degarelix.

Excess maternal weight, especially obesity, influences almost every aspect of fertility, from conception to problems during pregnancy.

The investigators will use novel statistical methods to clarify the hormonal changes behind reproductive health conditions.

A better understanding of reproductive hormonal changes in obese women may offer a way to identify new treatments.

It had two arms (groups): Frequent Blood Sampling, Degarelix (experimental) and Frequent Blood Sampling, Cetrorelix (experimental).

The registry classes the interventions as drug.

More on the Plan

Serial inhibin B and E2 levels will be measured in obese and normal weight women undergoing frequent blood sampling studies before and after GnRH (Gonadotropin-releasing hormone) antagonist blockade.

Who Took Part

The registry lists 99 actual participants took part.

It was open to women only aged from 21 years up to 39 years.

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

Examples of who could join: Age between 21 to 39 years old with regular menstrual cycles every 25-40 days. Body mass of 18.5 kg/m2-24.9kg/m2 (normal weight controls) or greater than 30.0 kg/m2 (obese group). Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening. Baseline hemoglobin \>11 gm/dl.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: history of chronic disease affecting hormone production, metabolism or clearance or use of thiazolidinediones or metformin (known to interact with reproductive hormones); use of hormones affecting hypothalamic-pituitary-gonadal (hpo) axis (such as hormonal contraceptives) within 3 months of entry; strenuous exercise (\>4 hours of intense physical activity per week).

How the Study Was Run

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

Nothing was hidden in this open-label Cetrorelix study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-07 with completion listed for 2021-06-30.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Difference Between Peak Inhibin B (time frame: Every 10 minutes over 2 10-hour frequent blood sampling sessions).

It also tracked 2 secondary outcomes, for example Peak Inhibin B Per Subject and Peak E2 Per Subject.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cetrorelix and Degarelix in 99 people.

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

More context: the Cetrorelix compound page and the Degarelix compound page, all human trials.