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

TF005

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?

2023-10-13

2024-10-30

2024-10-30

Recruiting

Early phase I

30

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-02-05