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Completed

NCT Number: NCT06117982

The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

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?

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Key information

Conditions

Primary Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Premature Ovarian Failure Urogenital Diseases

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Trio Fertility

Toronto, Ontario, M5G 2K4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neupogen

Drug

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

Other names: Filgrastim

Primary outcomes

  1. Improving ovarian reserve markers

    Time frame: 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 outcomes

  1. Successful Pregnancy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Trio Fertility

Other

Registry information

Official study title

Does Subcutaneous Granulocyte Colony Stimulating Factor (G-CSF) Improve Ovarian Reserve in Women With Premature Ovarian Insufficiency?

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2023
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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