ObesityNCT02478775
Dysregulation of FSH in Obesity: Functional and Statistical Analysis
A study testing Degarelix (GnRH antagonist), recombinant FSH and Cetrorelix in people with Obesity and Fertility, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women onlyHealthy volunteers can take part
- What is being tested?
- Degarelix (GnRH antagonist), recombinant FSH and Cetrorelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, 80045
About this study
Official title: Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis
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.
Read the detailed description
Hypothesis. Insufficient FSH (Follicle-stimulating hormone) pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production.
AIM: To test the hypothesis that insufficient FSH pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production. The investigators will determine if exogenous FSH administered in a pulsatile fashion results in a significant increase of ovarian hormones in obese women. 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.
- Being tested
- Degarelix (GnRH antagonist), recombinant FSH, Cetrorelix
- Keywords
- obesity, fertility, infertility, reproductive hormones
- Medical subject headings
- Obesity, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degarelix (GnRH antagonist)Drug
Also called Firmagon
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.
recombinant FSHDrug
Also called rFHS
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.
CetrorelixDrug
Also called Cetrotide
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.
| Study group | Role | What they receive |
|---|---|---|
| Frequent Blood Sampling, Degarelix | Experimental | 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. Receives: Drug: Degarelix (GnRH antagonist); Drug: recombinant FSH |
| Frequent Blood Sampling, Cetrorelix | Experimental | 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. Receives: Drug: recombinant FSH; Drug: Cetrorelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 10 minutes over 2 10-hour frequent blood sampling sessions.
Secondary outcomes (2)
Peak Inhibin B Per Subject
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.
Measured: Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.
Peak E2 Per Subject
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.
Measured: Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Alex Polotsky, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478775
- Sponsor's protocol ID
- 15-0474
- Other IDs
- UL1TR001082
- Status last verified
- May 2024
- First submitted
- 7 May 2015
- Last updated
- 5 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37276947
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis
- ClinicalTrials.gov ID
- NCT02478775
- Acronym / sponsor ID
- 15-0474
- Keywords
- obesity, fertility, infertility, reproductive hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jul 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Posted 7 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis. Insufficient FSH (Follicle-stimulating hormone) pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production.
AIM: To test the hypothesis that insufficient FSH pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production. The investigators will determine if exogenous FSH administered in a pulsatile fashion results in a significant increase of ovarian hormones in obese women. 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frequent Blood Sampling, Degarelix | Experimental | Drug: Degarelix (GnRH antagonist), Drug: recombinant FSHInvestigators 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 | Experimental | Drug: recombinant FSH, Drug: CetrorelixInvestigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Degarelix (GnRH antagonist)Also: FirmagonDay-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. | Drug | Frequent Blood Sampling, Degarelix |
| recombinant FSHAlso: rFHSDay-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. | Drug | Frequent Blood Sampling, Cetrorelix, Frequent Blood Sampling, Degarelix |
| CetrorelixAlso: CetrotideDay-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. | Drug | Frequent Blood Sampling, Cetrorelix |
Primary outcome
Difference Between Peak Inhibin B
Time frame: Every 10 minutes over 2 10-hour frequent blood sampling sessions.
This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.
2 secondary outcomes
Peak Inhibin B Per Subject
Time frame: Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.
Peak E2 Per Subject
Time frame: Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37276947Luu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Polotsky, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Degarelix (GnRH antagonist), recombinant FSH and Cetrorelix in people with Obesity and Fertility, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between Peak Inhibin B (time frame: Every 10 minutes over 2 10-hour frequent blood sampling sessions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02478775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.