FIL-POI: Filgrastim for Premature Ovarian Insufficiency

Sponsor

South Valley University (Other)

Overall Status

Completed

CT.gov ID

NCT02783937

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Premature Ovarian Failure	Biological: Filgrastim Drug: Saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Filgrastim for Treatment of Premature Ovarian Insufficiency: Randomized Clinical Trial

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Filgrastim arm Intervention: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days	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. Other Names: Granulocyte-Colony Stimulating Factor (G-CSF)
Placebo Comparator: Placebo arm Intervention: Injection of saline SC injection twice daily for five consecutive days.	Drug: Saline Injection of saline SC injection twice daily for five consecutive days Other Names: placebo

Arm

Intervention/Treatment

Active Comparator: Filgrastim arm

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

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.

Other Names:

Granulocyte-Colony Stimulating Factor (G-CSF)

Placebo Comparator: Placebo arm

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

Drug: Saline

Injection of saline SC injection twice daily for five consecutive days

Other Names:

placebo

Outcome Measures

Primary Outcome Measures

Return of menses [6 months]
Return of menses in patients with amenorrhea of at least 4 months

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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).