Status:
COMPLETED
The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency
Lead Sponsor:
Trio Fertility
Conditions:
Primary Ovarian Insufficiency
Premature Ovarian Failure
Eligibility:
FEMALE
25-40 years
Phase:
PHASE2
Brief 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 improve...
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06117982
Start Date
October 13 2023
End Date
May 1 2025
Last Update
May 8 2025
Active Locations (1)
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1
Trio Fertility
Toronto, Ontario, Canada, M5G 2K4