drugset / Trial / NCT06414096
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gonal-f | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 450 iu | Subcutaneous |