Clinical trial

Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis

Name

15-0474

Description

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.

Trial arms

Trial start

2015-07-01

Estimated PCD

2021-06-30

Trial end

2021-06-30

Status

Completed

Treatment

Degarelix (GnRH antagonist)

Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist degarelix will be given subcutaneously.

Arms:

Frequent Blood Sampling, Degarelix

Other names:

Firmagon

recombinant FSH

Day-2: Blood samples will again be obtained every 10 minutes for 10 hours. Repeated boluses of exogenous recombinant FSH (rFSH) will be given by IV during this 10 hour visit.

Arms:

Frequent Blood Sampling, Cetrorelix, Frequent Blood Sampling, Degarelix

Other names:

rFHS

Cetrorelix

Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist Cetrorelix will be given subcutaneously.

Arms:

Frequent Blood Sampling, Cetrorelix

Other names:

Cetrotide

Size

Primary endpoint

Difference Between Peak Inhibin B

Every 10 minutes over 2 10-hour frequent blood sampling sessions.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosis of polycystic ovary syndrome (PCOS), defined by the 2003 Rotterdam criteria as suggested by 2012 NIH Workshop * 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) * Pregnancy * Breast-feeding * Current attempts to conceive * Significant recent weight loss or gain

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 99, 'type': 'ACTUAL'}}

Updated at

2024-06-05

1 organization

3 products

2 indications

Organization

University of Colorado Denver

Product

Indication

Indication

Product

Product