Filgrastim for Premature Ovarian Insufficiency (FIL-POI)

South Valley University

Status and phase: Completed; Phase 4

Conditions: Premature Ovarian Failure

Treatments: Drug: Saline; Biological: Filgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT02783937

OBGYN001

Details and patient eligibility

About

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).

Full 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).

Enrollment: 10 patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Filgrastim arm

Active Comparator group

Description:

Intervention: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days

Treatment:

Biological: Filgrastim

Placebo arm

Placebo Comparator group

Description:

Intervention: Injection of saline SC injection twice daily for five consecutive days.

Treatment:

Drug: Saline