NCT06117982

The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

Does Subcutaneous Granulocyte Colony Stimulating Factor (G-CSF) Improve Ovarian Reserve in Women With Premature Ovarian Insufficiency?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Trio Fertility · Academic / Other
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this pilot study is to improve ovarian reserve markers in patients with premature ovarian insufficiency. The main question it aims to answer is: \- Will treatment with G-CSF allow improvement in markers of ovarian reserve?

Detailed description

The research team hypothesize that treatment of premature ovarian insufficiency patients with G-CSF to mobilize bone marrow hematopoietic stem cells will allow for improved ovarian reserve markers including antral follicle count, anti-Mullerian hormone (AMH) levels and gonadotropin (FSH) levels. The research team anticipate these outcomes: * Primary outcome: Decreased serum FSH and increased AMH levels and u/s measurement of increased antral follicle count (AFC) * Secondary outcome: Improved ovarian response in IVF cycles if BAFs develop, and spontaneous or IVF pregnancy.

Conditions

• Primary Ovarian Insufficiency
• Premature Ovarian Failure

Interventions

Type	Name	Description
DRUG	Neupogen	Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days

Timeline

• Start date: 2023-10-13
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2023-11-07
• Last updated: 2025-05-08

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study