Recruiting
Phase 4

G-CSF

Sponsor:

Center for Human Reproduction

Code:

NCT07871825

Conditions

Diminished Ovarian Reserve

IVF

G-CSF

Granulocyte Colony Stimulating Factor

Eligibility Criteria

Sex: Female

Age: 35 - 44

Healthy Volunteers: Not accepted

Interventions

Neupogen 300 μg subcutaneous injection

Subcutaneous injections of a saline solution

Study Details

Brief summary:

Diminished ovarian reserve (DOR) is defined by reduced follicle counts in women, associated with decreased fertility and lower success rates with In Vitro Fertilization (IVF). Granulocyte Colony Stimulating Factor (G-CSF) is a medication that has been proposed as a potential treatment for DOR, as it may help to improve ovarian function and increase the number of mature eggs available for fertilization. However, the efficacy and safety of G-CSF for DOR in IVF patients have not been definitively established. Therefore, our research protocol aims to assess the effectiveness of G-CSF in improving IVF outcomes in patients with DOR in POSEIDON group 4 (age ≥35 years and AMH <1.2 ng/mL).

In this double-blinded randomized controlled trial, 140 participants with DOR will receive subcutaneously 5 single doses of 300 μg of G-CSF (Neupogen, study group) or saline solution (placebo, control group), administered as one injection every other day starting in early luteal phase and for a total of 10 days, during standard IVF priming. All participants will undergo ovarian stimulation for IVF in the subsequent menstrual cycle following CHR's clinical protocols.

The primary outcomes will be the total number of eggs and of mature eggs retrieved. Secondary outcomes will include maturation, fertilization, viable day 3 or day 5 high quality embryos and clinical pregnancies, as well as collecting safety data.

Findings of this study may help to clarify the effect of G-CSF on ovarian function and IVF outcomes in women with DOR.

Conditions

Diminished Ovarian Reserve

IVF

G-CSF

Granulocyte Colony Stimulating Factor

Study ID

NCT07871825

Start date

Feb 25, 2026

Status verified date

Oct, 2026

Completion date

Feb 25, 2031

Anticipated

Primary completion date

Feb 25, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 44

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infertile women aged 35-44 years who have indication to undergo IVF and meet the POSEIDON group 4 (DOR): FSH <10 IU/L and AMH >1.2 ng/mL
  • Participants will be recruited from patients undergoing IVF treatment at The CHR

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: G-CSF group

placebo comparator: Placebo group

Interventions

Neupogen 300 μg subcutaneous injection

Participants in the G-CSF group will receive a Neupogen 300 μg subcutaneous injection every other day, starting in early luteal phase and until completing 5 doses (10-day-course).

Both the G-CSF group and the placebo group will initiate standard controlled ovarian stimulation (COS) with gonadotropins within the following menstrual cycle according to the clinic's protocols.

Subcutaneous injections of a saline solution

Participants in the placebo group will receive subcutaneous injections of a saline solution instead, following the same schedule.

Both the G-CSF group and the placebo group will initiate standard controlled ovarian stimulation (COS) with gonadotropins within the following menstrual cycle according to the clinic's protocols.

Primary outcome measure

  • Number of total and mature eggs retrieved [ Time Frame: 10-day-course ]

Central Contacts and Locations

Locations

The Center for Human Reproduction

Recruiting

New York, New York, United States, 10021

Contacts

David Barad, Principal Investigator, MD

2129944400dbarad@theCHR.com

More Information

Sponsor

Center for Human Reproduction

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Center for Human Reproduction on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.