Diminished Ovarian ReservePhase 4NCT07871825
Study of G-CSF for DOR in Patients Undergoing IVF
A Phase 4 study testing Neupogen 300 μg subcutaneous injection and Subcutaneous injections of a saline solution in people with Diminished Ovarian Reserve and IVF, run by Center for Human Reproduction at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 44 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve, IVF, G-CSF
- What is being tested?
- Neupogen 300 μg subcutaneous injection and Subcutaneous injections of a saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to 25 Feb 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Center for Human Reproduction
New York, New York, 10021
David Barad, Principal Investigator, MD, 2129944400, dbarad@theCHR.com
About this study
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)
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.
Read more
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.
- Being tested
- Neupogen 300 μg subcutaneous injection, Subcutaneous injections of a saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neupogen 300 μg subcutaneous injectionDrug
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 solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| G-CSF group | Active comparator | Not described Receives: Drug: Neupogen 300 μg subcutaneous injection |
| Placebo group | Placebo comparator | Not described Receives: Other: Subcutaneous injections of a saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-day-course
Secondary outcomes (1)
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.
Measured: 10-day-course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start25 Feb 2026
- Primary completion25 Feb 2030 (estimated)
- Study completion25 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871825
- Sponsor's protocol ID
- 0205206-03
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07871825
- Acronym / sponsor ID
- 0205206-03
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 25 Feb 2030 (estimated)
- Study completion
- 25 Feb 2031 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF group | Active comparator | Drug: Neupogen 300 μg subcutaneous injection |
| Placebo group | Placebo comparator | Other: Subcutaneous injections of a saline solution |
Who may qualify
- Ages
- 35 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neupogen 300 μg subcutaneous injectionParticipants 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. | Drug | G-CSF group |
| Subcutaneous injections of a saline solutionParticipants 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. | Other | Placebo group |
Primary outcome
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.
1 secondary outcome
Maturation, fertilization, number of viable day 3 or day 5 high quality embryos, chemical and clinical pregnancies
Time frame: 10-day-course
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neupogen 300 μg subcutaneous injection and Subcutaneous injections of a saline solution in people with Diminished Ovarian Reserve and IVF, run by Center for Human Reproduction at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of total and mature eggs retrieved (time frame: 10-day-course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.