The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

Last updated: May 5, 2025
Sponsor: Trio Fertility
Overall Status: Completed

Phase

2

Condition

Perimenopause

Female Hormonal Deficiencies/abnormalities

Treatment

Neupogen

Clinical Study ID

NCT06117982
TF005
  • Ages 25-40
  • Female
  • Accepts Healthy Volunteers

Study 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?

Eligibility Criteria

Inclusion

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, nightsweats, insomnia and vaginal dryness.

  • Women who are not taking any other medical or fertility treatments except naturalestrogen to stop hot flushes.

  • Those who are provided with informed consent.

Exclusion

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 andpregnancy such as HIV/AIDS, hepatitis B or C, breast cancer or body mass index (BMI) >40.

Study Design

Total Participants: 11
Treatment Group(s): 1
Primary Treatment: Neupogen
Phase: 2
Study Start date:
October 13, 2023
Estimated Completion Date:
May 01, 2025

Study 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.

Connect with a study center

  • Trio Fertility

    Toronto, Ontario M5G 2K4
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.