NCT02783937

Filgrastim for Premature Ovarian Insufficiency

Filgrastim for Treatment of Premature Ovarian Insufficiency: Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: South Valley University · Academic / Other
• Sex: Female
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Premature Ovarian Failure

Interventions

Type	Name	Description
BIOLOGICAL	Filgrastim	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.
DRUG	Saline	Injection of saline SC injection twice daily for five consecutive days

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-12-01
• Completion: 2021-06-01
• First posted: 2016-05-26
• Last updated: 2021-09-21