Clinical trial NCT06117982: The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency
Official title: Does Subcutaneous Granulocyte Colony Stimulating Factor (G-CSF) Improve Ovarian Reserve in Women With Premature Ovarian Insufficiency?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Ovarian Insufficiency
Premature Ovarian Failure
Keywords: Filgrastim
Granulocyte colony stimulating factor
Premature Ovarian Insufficiency
Neupogen
Lead sponsor: Trio Fertility
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 11
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 improvement in markers of ovarian reserve?

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improving ovarian reserve markers
timeFrame: It is anticipated within six months
Secondary outcomes:
measure: Successful Pregnancy
timeFrame: It is anticipated after the first six months of the study time frame
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Trio Fertility
state: Ontario
Study officials:
affiliation: Trio Fertility, Toronto, ON, Canada
name: Robert F. Casper, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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 peripheral blood or bone marrow transplantation: a retrospective survey. Lancet. 2001 Jul 28;358(9278):271-6. doi: 10.1016/s0140-6736(01)05482-4.
citation: Pellicer, N, Herraiz, S, Romeu, M, Martinez, S, Buiges, A, Gomez-Seguí, I, Martínez, 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 mobilization versus ovarian injection. 36th Annual Meeting of European Society Reproduction and Embryology (ESHRE).