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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06414096
The ClinicalTrials.gov registry entry for NCT06414096 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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