Dysregulation of FSH in Obesity: Functional and Statistical Analysis
Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis
2 other identifiers
interventional
99
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jul 2015
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
April 7, 2022
CompletedJune 5, 2024
May 1, 2024
6 years
May 7, 2015
January 12, 2022
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference Between Peak Inhibin B
This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.
Every 10 minutes over 2 10-hour frequent blood sampling sessions.
Secondary Outcomes (2)
Peak Inhibin B Per Subject
Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.
Peak E2 Per Subject
Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.
Study Arms (2)
Frequent Blood Sampling, Degarelix
EXPERIMENTALInvestigators 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.
Frequent Blood Sampling, Cetrorelix
EXPERIMENTALInvestigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, 80045, United States
Related Publications (1)
Luu TH, Kuhn K, Bradford AP, Wempe MF, Wittenburg L, Johnson RL, Carlson NE, Kumar TR, Polotsky AJ. Effects of pulsatile intravenous follicle-stimulating hormone treatment on ovarian function in women with obesity. Fertil Steril. 2023 Oct;120(4):890-898. doi: 10.1016/j.fertnstert.2023.05.170. Epub 2023 Jun 3.
PMID: 37276947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The Degarelix arm is excluded from outcome measure data because no usable data could be collected from those normal weight participants. There were no participants in this arm that were of high BMI. The Degarelix arm was terminated due to adverse events and was replaced with the Cetrorelix arm.
Results Point of Contact
- Title
- Dr. Alex Polotsky
- Organization
- University of Colorado School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Polotsky, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2015
First Posted
June 23, 2015
Study Start
July 1, 2015
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
June 5, 2024
Results First Posted
April 7, 2022
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share