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Cytokine

Neupogen for Premature Ovarian Insufficiency

Phase 2

Recruiting

Led By Robert F. Casper, Dr.

Research Sponsored by Trio Fertility

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Woman who meet criteria for POI defined as AFC < 5, AMH < 3 pmol/L and FSH >30 IU/L. There may also be associated symptoms of the menopause such as hot flushes, night sweats, insomnia and vaginal dryness.

Women ages 25-40

Timeline

Screening 3 weeks

Treatment Varies

Follow Up it is anticipated within six months

Awards & highlights

Study Summary

This trial will help determine if a medication can help improve fertility in women with premature ovarian insufficiency.

Who is the study for?

This trial is for women aged 25-40 with premature ovarian insufficiency (POI), characterized by low ovarian reserve markers. Participants should not be on other medical or fertility treatments, except natural estrogen, and must provide informed consent. Women over 40, those with certain diseases like HIV/AIDS, hepatitis B/C, breast cancer, autoimmune disorders or a BMI >40 are excluded.Check my eligibility

What is being tested?

The study tests whether Granulocyte Colony Stimulating Factor (G-CSF), marketed as Neupogen, can improve ovarian reserve markers in patients with POI. It's a pilot study to see if this treatment could potentially alleviate symptoms of menopause caused by POI.See study design

What are the potential side effects?

While the specific side effects for this trial aren't listed here, G-CSF commonly includes bone pain, headaches, nausea and vomiting. There may also be redness or irritation at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman with early menopause symptoms and specific hormone levels.

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I am a woman aged between 25 and 40.

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I am a woman not on any medication except natural estrogen for hot flushes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ it is anticipated after the first six months of the study time frame

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~it is anticipated after the first six months of the study time frame

This trial's timeline: 3 weeks for screening, Varies for treatment, and it is anticipated after the first six months of the study time frame for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improving ovarian reserve markers

Secondary outcome measures

Successful Pregnancy

Side effects data

From 2016 Phase 2 trial • 42 Patients • NCT01181271

14%

platelet count decreased

12%

febrile neutropenia

10%

anemia

10%

diarrhea

10%

mucositis oral

10%

dyspnea

muscle weakness

nausea

colitis

edema

neutrophil count decreased

weight loss

respiratory failure

Death, not otherwise specified

Adult Respiratory Distress Syndrome

Atrioventricular block

sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Autologous Then Allogeneic Transplant

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with POI receiving G-CSF injectionsExperimental Treatment1 Intervention

Patients will receive 0.5 ml SC injections of G-CSF (Neupogen, Amgen, USA) at 300 micrograms/day for 4 consecutive days. The first injection will be administered in our office with a 60-minute observation period. Subsequent injections can be self-administered at home for three days, with a return to our clinic for monitoring the following day. This 4-day Neupogen regimen will be repeated in one month. Patients may undergo two rounds of G-CSF treatment one month apart. If no improvement is observed in gonadotropin, anti-Mullerian levels, and antral follicle count, a third treatment may be offered a month later. Follow-up includes blood assessment of AMH and FSH, as well as ultrasound measurement of basal antral follicle count for three months after the last G-CSF infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neupogen

2007

Completed Phase 4

~970

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Trio FertilityLead Sponsor

Robert F. Casper, Dr.Principal InvestigatorTrio Fertility, Toronto, ON, Canada

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals over the age of fifty-five have access to this research study?

"The investigators of this study are currently seeking participants aged 25 to 40."

Answered by AI

Are there still spots available to join this experiment?

"Affirmative, the clinical trial is actively recruiting. The study was initially advertised on October 13th 2023 and had its information most recently updated on October 31st of the same year. With 1 site as a part of this experiment, 30 patients must be enrolled in order for it to move forward."

Answered by AI

How many individuals are currently involved in this medical research?

"Confirmed. According to clinicaltrials.gov, this medical trial was initially posted on October 13th 2023 and is presently searching for 30 patients from one site. The record of the study has been updated as recently as October 31st 2023."

Answered by AI

What risks are associated with utilizing G-CSF injections in persons of infertility?

"Power's internal assessment placed the safety of G-CSF injections for Patients with POI at a 2 due to Phase 2 clinical trial data, which suggested that it is safe but has yet to demonstrate efficacy."

Answered by AI

To whom is this investigation open for participation?

"Qualified applicants for this investigation must be between 25 and 40 years old with primary ovarian insufficiency. The research team requires a total of 30 participants to commence the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

Dr. Robert F. Casper 2023. "The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06117982.

All > Premature Ovarian Failure