The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117982
• Other study ID #: TF005
• Status: Recruiting
• Phase: Phase 2
• Start date: October 13, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: Trio Fertility
• Contact: Robert F. Casper, Dr
• Phone: 416-506-0804
• Email: casper[@]lunenfeld.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Drug:
• Neupogen
Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days

Locations

Country	Name	City	State
Canada	Trio Fertility	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Trio Fertility

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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

Outcome

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

External Links

•   Bone marrow derived stem cells restore ovarian function and fertility in premature ovarian insufficiency women. Interim report of a randomized trial: mobilization versus ovarian injection