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Recruiting Phase 4 Interventional

Study of G-CSF for DOR in Patients Undergoing IVF

ClinicalTrials.gov ID: NCT07871825

Public ClinicalTrials.gov record NCT07871825. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 14, 2026, 3:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Research Protocol for a Double-Blinded Randomized Trial of Granulocyte Colony Stimulating Factor (G-CSF) for Treatment of Diminished Ovarian Reserve in Patients Undergoing In Vitro Fertilization (IVF)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07871825
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Enrollment
140 participants

Conditions and interventions

Eligibility (public fields only)

Age range
35 Years to 44 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 25, 2026 (Actual)
Primary completion
Feb 25, 2030 (Estimated)
Completion
Feb 25, 2031 (Estimated)
Last update posted
Oct 13, 2026

2026 – 2031

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The Center for Human Reproduction New York New York 10021 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07871825, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2026 · Synced Oct 14, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07871825 live on ClinicalTrials.gov.

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