The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

NCT06117982 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: TF005
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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?

Conditions

Primary Ovarian Insufficiency; Premature Ovarian Failure

Keywords

Filgrastim; Granulocyte colony stimulating factor; Premature Ovarian Insufficiency; Neupogen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Successful Pregnancy

  It is anticipated after the first six months of the study time frame

Study Arms (1)

Patients with POI receiving G-CSF injections

EXPERIMENTAL

Patients will receive 0.5 ml SC injections of G-CSF (Neupogen, Amgen, USA) at 300 micrograms/day for 4 consecutive days. The first injection will be administered in our office with a 60-minute observation period. Subsequent injections can be self-administered at home for three days, with a return to our clinic for monitoring the following day. This 4-day Neupogen regimen will be repeated in one month. Patients may undergo two rounds of G-CSF treatment one month apart. If no improvement is observed in gonadotropin, anti-Mullerian levels, and antral follicle count, a third treatment may be offered a month later. Follow-up includes blood assessment of AMH and FSH, as well as ultrasound measurement of basal antral follicle count for three months after the last G-CSF infusion.

Drug: Neupogen

Interventions

Neupogen DRUG

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

Also known as: Filgrastim

Patients with POI receiving G-CSF injections

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trio Fertility: lead

Study Sites (1)

Trio Fertility

Toronto, Ontario, M5G 2K4, Canada

Location

Related Publications (4)

• 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.

  PMID: 11821109 RESULT

• 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.

  PMID: 11498213 RESULT

• 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).

  RESULT

• Sadeghi Y, Deda L, Albar M, Casper R. Granulocyte colony-stimulating factor treatment in women with premature ovarian insufficiency: a pilot clinical study of biological activity and menstrual resumption. Reprod Biol Endocrinol. 2026 Jan 7. doi: 10.1186/s12958-025-01510-z. Online ahead of print.

  PMID: 41495818 DERIVED

Related 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

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Robert F. Casper, Dr.

  Trio Fertility, Toronto, ON, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, MD, FRCSC, REI

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: October 13, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

CA (1)