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).

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Study Start: 2016-11
• Primary Completion: 2020-12
• Study Completion: 2021-06
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

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

Group	Intervention	Description
Filgrastim arm	Filgrastim	Intervention: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days
Placebo arm	Saline	Intervention: Injection of saline SC injection twice daily for five consecutive days.

Primary Outcome Measures

Name	Time	Method
Return of menses	6 months	Return of menses in patients with amenorrhea of at least 4 months

Secondary Outcome Measures

Name	Time	Method
Pregnancy	6 months	Occurrence of pregnancy as diagnosed by positive serum B-hCG and/or ultrasound
serum Estradiol	6 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 FSH	6 months	Normalization of serum FSH in patients with FSH level above 25 IU/L
Follicular growth	6 months	Growth of follicle to size at least 18 mm as monitored by transvaginal ultrasound
endometrial thickness	6 months	increase of endometrial thickness in women with thin endometrium (less then 8 mm)