The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

Phase 2

Completed

• Conditions: Primary Ovarian Insufficiency; Premature Ovarian Failure
• Interventions: Drug: Neupogen

• Registration Number: NCT06117982
• Lead Sponsor: Trio Fertility

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.

Study Timeline

• Study Start: 2023-10-13
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-07
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with POI receiving G-CSF injections	Neupogen	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.

Primary Outcome Measures

Name	Time	Method
Improving ovarian reserve markers	It is anticipated within six months	Success of the treatment will be assessed by a change in serum FSH, AMH (measure of ovarian reserve) and number of antral follicles (AFC).

Secondary Outcome Measures

Name	Time	Method
Successful Pregnancy	It is anticipated after the first six months of the study time frame	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.

Trial Locations

Locations (1)

Trio Fertility; 🇨🇦 Toronto, Ontario, Canada