NCT07871825 · Center for Human Reproduction
Study of G-CSF for DOR in Patients Undergoing IVF
What this study is about
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).
View original scientific description
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.
Interventions
DRUG
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.
OTHER
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 measures
Number of total and mature eggs retrieved
Time frame: 10-day-course
The total and mature oocyte yield resulting from ovarian stimulation cycles will be analyzed using a t-Student test, comparing the G-CSF vs. placebo groups. Binary logistic regression will be used to compare the odds of obtaining mature eggs between study groups adjusted for adjusting for age, AMH, BMI, and other baseline variables if considered appropriate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 13, 2026 · Source of record for eligibility and locations