Filgrastim for Premature Ovarian Insufficiency

South Valley University10 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Premature Ovarian Failure

Interventions

FilgrastimBIOLOGICAL

Each case will have two intervention phases done blindly at random with a wash-out period of 6 months: Phase A: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days. Phase B: Injection of saline SC injection twice daily for five consecutive days.

SalineDRUG

Injection of saline SC injection twice daily for five consecutive days

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Return of menses

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

Time frame: 6 months

Secondary Outcomes

Pregnancy

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

Time frame: 6 months

serum Estradiol

Normalization of serum Estradiol as tested bi-weekly

Time frame: 6 months

serum Anti-mullarian Hormone (AMH)

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

Time frame: 6 months

serum FSH

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

Time frame: 6 months

Follicular growth

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

Time frame: 6 months

endometrial thickness

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

Time frame: 6 months

Data from ClinicalTrials.gov

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