Trial Outcomes & Findings for The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency (NCT NCT06117982)
NCT ID: NCT06117982
Last Updated: 2026-08-20
Results Overview
Success of the treatment will be assessed by a change in serum FSH, AMH (measure of ovarian reserve) and number of antral follicles (AFC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2026-08-20
Participant Flow
Participant milestones
| Measure |
Patients With POI Receiving G-CSF Injections
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 (pmol/L) and FSH (IU/L), as well as ultrasound measurement of basal antral follicle count for three months after the last G-CSF infusion.
Neupogen: Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days
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|---|---|
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Overall Study
STARTED
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11
|
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With POI Receiving G-CSF Injections
n=11 Participants
15 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 (pmol/L), and antral follicle count, a third treatment may be offered a month later. Follow-up includes blood assessment of AMH and FSH levels, as well as ultrasound measurement of basal antral follicle count for three months after the last G-CSF infusion.
Neupogen: Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=11 Participants
|
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Age, Categorical
Between 18 and 65 years
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11 Participants
n=11 Participants
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Age, Categorical
>=65 years
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0 Participants
n=11 Participants
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Age, Continuous
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34.1 years
STANDARD_DEVIATION 5.2 • n=11 Participants
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Sex: Female, Male
Female
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11 Participants
n=11 Participants
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Sex: Female, Male
Male
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0 Participants
n=11 Participants
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Region of Enrollment
Canada
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11 participants
n=11 Participants
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PRIMARY outcome
Timeframe: Baseline to Month 12Success of the treatment will be assessed by a change in serum FSH, AMH (measure of ovarian reserve) and number of antral follicles (AFC).
Outcome measures
| Measure |
Patients With POI Receiving G-CSF Injections
n=11 Participants
15 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 (pmol/L), and antral follicle count, a third treatment may be offered a month later. Follow-up includes blood assessment of AMH and FSH levels, as well as ultrasound measurement of basal antral follicle count for three months after the last G-CSF infusion.
Neupogen: Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days
|
|---|---|
|
FSH Level (IU/L)
FSH level (IU/L) at Baseline
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54.26 IU/L
Standard Deviation 24.65
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FSH Level (IU/L)
FSH level (IU/L) at Month 12
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23.05 IU/L
Standard Deviation 10.86
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PRIMARY outcome
Timeframe: Baseline to Month 12AMH level for ovarian reserve
Outcome measures
| Measure |
Patients With POI Receiving G-CSF Injections
n=11 Participants
15 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 (pmol/L), and antral follicle count, a third treatment may be offered a month later. Follow-up includes blood assessment of AMH and FSH levels, as well as ultrasound measurement of basal antral follicle count for three months after the last G-CSF infusion.
Neupogen: Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days
|
|---|---|
|
AMH Level (Pmol/L)
AMH level (pmol/L) at Baseline
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0.21 pmol/L
Standard Deviation 0.15
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AMH Level (Pmol/L)
AMH level (pmol/L) at Month 12
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0.10 pmol/L
Standard Deviation 0.04
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SECONDARY outcome
Timeframe: From Baseline to Month 12If 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.
Outcome measures
| Measure |
Patients With POI Receiving G-CSF Injections
n=11 Participants
15 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 (pmol/L), and antral follicle count, a third treatment may be offered a month later. Follow-up includes blood assessment of AMH and FSH levels, as well as ultrasound measurement of basal antral follicle count for three months after the last G-CSF infusion.
Neupogen: Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days
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|---|---|
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Successful Pregnancy
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0 Participants
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Adverse Events
Patients With POI Receiving G-CSF Injections
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients With POI Receiving G-CSF Injections
n=11 participants at risk
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.
Neupogen: Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days
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|---|---|
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Musculoskeletal and connective tissue disorders
Lower Back Pain
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54.5%
6/11 • Number of events 6 • from enrollment until end of receiving the treatment, up to one month
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Nervous system disorders
Headache
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45.5%
5/11 • Number of events 5 • from enrollment until end of receiving the treatment, up to one month
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General disorders
Fatigue
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18.2%
2/11 • Number of events 2 • from enrollment until end of receiving the treatment, up to one month
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General disorders
Injection Site Discomfort
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9.1%
1/11 • Number of events 1 • from enrollment until end of receiving the treatment, up to one month
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place