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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

Must not have

Women with any other comorbidities that would preclude infertility treatment and pregnancy such as HIV/AIDS, hepatitis B or C, breast cancer or body mass index (BMI) >40.

Women with age > 40

Timeline

Screening 3 weeks

Treatment Varies

Follow Up it is anticipated within six months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like HIV/AIDS, hepatitis B/C, breast cancer, or a BMI over 40 that would prevent pregnancy.

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I am a woman older than 40.

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I am a woman who has had blood cancer.

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I am a woman with sickle cell disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improving ovarian reserve markers

Secondary study objectives

Successful Pregnancy

Side effects data

From 2016 Phase 2 trial • 42 Patients • NCT01181271

14%

platelet count decreased

12%

febrile neutropenia

10%

diarrhea

10%

mucositis oral

10%

anemia

10%

dyspnea

muscle weakness

nausea

colitis

edema

neutrophil count decreased

weight loss

respiratory failure

Adult Respiratory Distress Syndrome

Atrioventricular block

Death, not otherwise specified

sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Autologous Then Allogeneic Transplant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met