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NCT06414096 · ClinicalTrials.gov registry record · Phase 1
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
A Phase 1 study of Obesity and Infertility, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT06414096: Recruiting Phase 1 study of Obesity and Infertility, sponsored by University of Colorado, Denver.
NCT06414096 is a Phase 1 study of Obesity and Infertility that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 5 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06414096, a Phase 1 study of Obesity and Infertility, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypothesis: The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome (RMS) luteal deficiency phenotype. Specific Aim: To test the hypothesis that pulsatile IV administration of FSH will rescue the impaired folliculogenesis and relative hypogonadotropic hypogonadism, characteristic of obesity. The investigators will accomplish this by administering a cycle of pulsatile FSH to women with obesity and comparing their hormone output to a cycle using conventional, daily FSH injection at the identical daily dose. The primary outcome will be luteal phase progesterone excretion.
Primary Outcome
The primary endpoint of the study is luteal progesterone metabolite (pregnanediol; Pdg) excretion. Luteal Pdg will be compared in the pulsatile FSH cycle to the daily dose subcutaneous (SQ) cycle. Patients who conceive in the cycle of study will not have their conception cycle included in the analysis.
Conditions Studied
Interventions
- DRUG Follicle Stimulating Hormone
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What NCT06414096 shows while recruiting
NCT06414096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Follicle Stimulating Hormone is the first listed.
NCT06414096 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06414096 about?
NCT06414096 is a clinical study titled "Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome". Hypothesis: The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome (RMS) luteal deficiency phenotype. Specific Aim: To test the hypothesis that pulsatile IV administration of FSH will rescue the impaired folliculoge...
What is the current status of trial NCT06414096?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2024-10-01. Estimated completion is 2026-11.
What conditions does trial NCT06414096 study?
This clinical trial studies the following conditions: Obesity, Infertility.
What interventions are being tested in trial NCT06414096?
The interventions under investigation include: Follicle Stimulating Hormone (DRUG).
Who is sponsoring clinical trial NCT06414096?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06414096 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06414096's enrollment target sits among peer trials
5 1050th of 1053 higher than 1 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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