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NCT Number: NCT02783937

Filgrastim for Premature Ovarian Insufficiency

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).

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Key information

Conditions

Premature Ovarian Failure Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Obstetric Labor Complications Obstetric Labor, Premature Ovarian Diseases Pregnancy Complications Premature Birth Primary Ovarian Insufficiency Urogenital Diseases

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

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)

Saline

Drug

Injection of saline SC injection twice daily for five consecutive days

Other names: placebo

Primary outcomes

  1. Return of menses

    Time frame: 6 months

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

Secondary outcomes

  1. Pregnancy

    Time frame: 6 months

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

  2. serum Estradiol

    Time frame: 6 months

    Normalization of serum Estradiol as tested bi-weekly

  3. serum Anti-mullarian Hormone (AMH)

    Time frame: 6 months

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

  4. serum FSH

    Time frame: 6 months

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

  5. Follicular growth

    Time frame: 6 months

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

  6. endometrial thickness

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Filgrastim for Treatment of Premature Ovarian Insufficiency: Randomized Clinical Trial

Acronym: FIL-POI

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
May 26, 2016
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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