drugset / Trial / NCT06414096

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

NCT06414096

Phase 1 Recruiting 5 enrolled University of Colorado, Denver
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2024-10-01
Primary completion
2025-11
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonal-f Protein / enzyme biologic 75 iu Subcutaneous
Subject Gonal-f Protein / enzyme biologic 450 iu Subcutaneous