Trial · Interventional

CompletedNot applicableResults postedRegistry data

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

NCTNCT02478775Other id15-0474Other idUL1TR001082

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 99 participants (actual)
Sponsor: University of Colorado, Denver · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jul 2015
Primary completion: 30 Jun 2021
Completion: 30 Jun 2021
First posted: 23 Jun 2015 (estimated)
Last update posted: 5 Jun 2024
Conditions: Obesity · Fertility

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2016201820202022

N/A
Dysregulation of FSH in Obesity: Functional and Statistical Analysis
NCT02478775
Jul 2015 to 30 Jun 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Degarelix (GnRH antagonist)Drug
recombinant FSHDrug
CetrorelixDrug

Arms2

Experimental
Frequent Blood Sampling, Degarelix
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.
Experimental
Frequent Blood Sampling, Cetrorelix
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.

Primary outcomes1

Outcomes the sponsor listed as primary.

Difference Between Peak Inhibin B
Time frame · Every 10 minutes over 2 10-hour frequent blood sampling sessions.
Registry description
This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.

Secondary outcomes(2)

Peak Inhibin B Per Subject
Time frame · Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.
Registry description
Peak inhibin B will be measured every 10 minutes during day 1 and day 2 of the study. The highest inhibin B value will be defined as the peak.
Peak E2 Per Subject
Time frame · Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.
Registry description
E2 will be measured every 10 minutes on Day 1 and Day 2 of the study. The highest E2 value will be designated as the peak E2 value.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Difference Between Peak Inhibin B

Group	Value (picograms/mL)	Spread
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight	100.8	73.7
Experimental: Frequent Blood Sampling, Cetrorelix: Obese	38.8	37.9

Secondary and other outcome results(2)

Secondary outcomeMean· Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.

Peak Inhibin B Per Subject

Group	Value (picograms/mL)	Spread
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight	103.5	43.8
Experimental: Frequent Blood Sampling, Cetrorelix: Obese	87.5	45.3

Secondary outcomeMean· Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.

Peak E2 Per Subject

Group	Value (pg/L)	Spread
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight	65.1	58.0
Experimental: Frequent Blood Sampling, Cetrorelix: Obese	72.5	37.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Experimental: Frequent Blood Sampling, DegarelixInvestigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product. BMI = 18.5 to 24.9 BMI	0 / 6	0 / 6	5 / 6
Experimental: Frequent Blood Sampling, Cetrorelix: Normal WeightInvestigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Normal weight participants = 18.5 to 24.9 BMI	0 / 27	0 / 27	0 / 27
Experimental: Frequent Blood Sampling, Cetrorelix: ObeseInvestigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Obese participants = BMI of \>30	0 / 27	0 / 27	0 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2023

Effects of pulsatile intravenous follicle-stimulating hormone treatment on ovarian function in women with obesity.

Luu et al. 2023Fertility and sterilitycited by 6

PMID 37276947PMC10526695DOI 10.1016/j.fertnstert.2023.05.170PUB-37276947

Rights unknown

Source link

Eligibility

Who could join, as posted.

Sex: Female
Age: from 21 Years up to 39 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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