A Phase 4 interventional study of Neupogen 300 μg subcutaneous injection and Subcutaneous injections of a saline solution in Diminished Ovarian Reserve, IVF and G-CSF, sponsored by Center for Human Reproduction. Recruiting at 1 site in United States. Open to female participants aged 35 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Center for Human Reproduction · Phase 4, Interventional, and Treatment
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.
Center for Human Reproduction is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Drug: Neupogen 300 μg subcutaneous injection
Other: Subcutaneous injections of a saline solution
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.
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.
Number of total and mature eggs retrieved
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.
Time frame: 10-day-course
Maturation, fertilization, number of viable day 3 or day 5 high quality embryos, chemical and clinical pregnancies
Number of viable day 3 or day 5 high quality embryos and clinical pregnancies will be compared using ANOVA.
Time frame: 10-day-course
Started Feb 2026 (actual). Primary completion is estimated for Feb 2030, 48 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Filgrastim
Center for Human Reproduction