MedPath

Filgrastim for Premature Ovarian Insufficiency

Phase 4
Completed
Conditions
Premature Ovarian Failure
Interventions
Biological: Filgrastim
Drug: Saline
Registration Number
NCT02783937
Lead Sponsor
South Valley University
Brief Summary

Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug. Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed that these cells are able to regenerate the affected ovary. Studies on mice have shown that Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).

Detailed Description

Premature ovarian insufficiency (POI) has no curative treatment until now. Filgrastim is an FDA approved Granulocyte-Colony Stimulating factor (G-CSF). Very small embryonic-like stem cells (VSELs) are found in the testis and ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal failure. Data from animal studies showed that stimulation of these stem cells result in generation of the affected gonads. Studies on mice have shown a promising stimulating effect of Filgrastim on recovery of spermatogenesis and oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
10
Inclusion Criteria
  • Women with Premature Ovarian Insufficiency (POI): For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice >4 weeks apart).
Exclusion Criteria
  • Abnormal karyotype
  • Previous pelvic or abdominal radiotherapy
  • Previous surgical removal of the ovarian pathology
  • Chronic disease: renal, liver, cardiac, malignancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Filgrastim armFilgrastimIntervention: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days
Placebo armSalineIntervention: Injection of saline SC injection twice daily for five consecutive days.
Primary Outcome Measures
NameTimeMethod
Return of menses6 months

Return of menses in patients with amenorrhea of at least 4 months

Secondary Outcome Measures
NameTimeMethod
Pregnancy6 months

Occurrence of pregnancy as diagnosed by positive serum B-hCG and/or ultrasound

serum Estradiol6 months

Normalization of serum Estradiol as tested bi-weekly

serum Anti-mullarian Hormone (AMH)6 months

Normalization of serum AMH in patients with AMH level less than 0.9 ng/mL

serum FSH6 months

Normalization of serum FSH in patients with FSH level above 25 IU/L

Follicular growth6 months

Growth of follicle to size at least 18 mm as monitored by transvaginal ultrasound

endometrial thickness6 months

increase of endometrial thickness in women with thin endometrium (less then 8 mm)

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