The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

• Status: Recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: Female

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?

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trio Fertility

Criteria

Inclusion Criteria:

• Women ages 25-40

• Woman who meet criteria for POI defined as AFC < 5, AMH < 3 pmol/L and FSH >30 IU/L. There may also be associated symptoms of the menopause such as hot flushes, night sweats, insomnia and vaginal dryness.

• Women who are not taking any other medical or fertility treatments except natural estrogen to stop hot flushes.

• Those who are provided with informed consent.

Exclusion Criteria:

• Women with age > 40

• Women with history of autoimmune disorders

• Women with a history of hematopoietic cell malignancies

• Women with sickle cell disease

• Women with any other comorbidities that would preclude infertility treatment and pregnancy such as HIV/AIDS, hepatitis B or C, breast cancer or body mass index (BMI) >40.