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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06117982
Other study ID # TF005
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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