Premature Ovarian Failure Clinical Trial
Official title:
Does Subcutaneous Granulocyte Colony Stimulating Factor (G-CSF) Improve Ovarian Reserve in Women With Premature Ovarian Insufficiency?
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?
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 30, 2024 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Trio Fertility | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Trio Fertility |
Canada,
Hershlag A, Schuster MW. Return of fertility after autologous stem cell transplantation. Fertil Steril. 2002 Feb;77(2):419-21. doi: 10.1016/s0015-0282(01)02987-9. — View Citation
Pellicer, N, Herraiz, S, Romeu, M, Martinez, S, Buiges, A, Gomez-Segui´, I, Marti´nez, J, Pellicer, A., 2020. Bone marrow derived stem cells restore ovarian function and fertility in women with POI: Interim report of a randomized trial comparing mobilizat
Salooja N, Szydlo RM, Socie G, Rio B, Chatterjee R, Ljungman P, Van Lint MT, Powles R, Jackson G, Hinterberger-Fischer M, Kolb HJ, Apperley JF; Late Effects Working Party of the European Group for Blood and Marrow Transplantation. Pregnancy outcomes after — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improving ovarian reserve markers | Success of the treatment will be assessed by a change in serum FSH, AMH (measure of ovarian reserve) and number of antral follicles (AFC). | It is anticipated within six months | |
Secondary | Successful Pregnancy | If a change in the number of basal antral follicles is seen in association with an FSH level below 20 IU/L, the subjects will be offered a cycle of IVF to see if oocytes and subsequently embryos can be obtained. | It is anticipated after the first six months of the study time frame |
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