Primary Ovarian InsufficiencyPhase 2NCT06117982
The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency
A Phase 2 study testing Neupogen in people with Primary Ovarian Insufficiency and Premature Ovarian Failure, run by Trio Fertility at 1 site in Canada.
Trial 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? Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Ovarian Insufficiency, Premature Ovarian Failure
- What is being tested?
- Neupogen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 13 Oct 2023to 1 May 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Subcutaneous Granulocyte Colony Stimulating Factor (G-CSF) Improve Ovarian Reserve in Women With 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?
Read the 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.
- Being tested
- Neupogen
- Keywords
- Filgrastim, Granulocyte colony stimulating factor, Premature Ovarian Insufficiency, Neupogen
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeupogenDrug
Also called Filgrastim
Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Neupogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSH Level (IU/L)
Success of the treatment will be assessed by a change in serum FSH, AMH (measure of ovarian reserve) and number of antral follicles (AFC).
Measured: Baseline to Month 12
AMH Level (Pmol/L)
AMH level for ovarian reserve
Measured: Baseline to Month 12
Secondary outcomes (1)
Successful Pregnancy
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.
Measured: From Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start13 Oct 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trio Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert F. Casper, Trio Fertility
- Investigators
- Robert F. Casper, Dr., Principal investigator, Trio Fertility, Toronto, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117982
- Sponsor's protocol ID
- TF005
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2023
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 11821109Salooja 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.
PubMed 11498213Pellicer, 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).
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;24(1):19. doi: 10.1186/s12958-025-01510-z.
PubMed 41495818