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Filgrastim for Premature Ovarian Insufficiency (FIL-POI)

Primary Purpose

Premature Ovarian Failure

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Filgrastim
Saline
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ovarian Failure focused on measuring Premature, Ovarian, Failure, Filgrastim

Eligibility Criteria

16 Years - 40 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Filgrastim arm

    Placebo arm

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Pregnancy
    Occurrence of pregnancy as diagnosed by positive serum B-hCG and/or ultrasound
    serum Estradiol
    Normalization of serum Estradiol as tested bi-weekly
    serum Anti-mullarian Hormone (AMH)
    Normalization of serum AMH in patients with AMH level less than 0.9 ng/mL
    serum FSH
    Normalization of serum FSH in patients with FSH level above 25 IU/L
    Follicular growth
    Growth of follicle to size at least 18 mm as monitored by transvaginal ultrasound
    endometrial thickness
    increase of endometrial thickness in women with thin endometrium (less then 8 mm)

    Full Information

    First Posted
    May 17, 2016
    Last Updated
    September 20, 2021
    Sponsor
    South Valley University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02783937
    Brief Title
    Filgrastim for Premature Ovarian Insufficiency
    Acronym
    FIL-POI
    Official Title
    Filgrastim for Treatment of Premature Ovarian Insufficiency: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    December 2020 (Actual)
    Study Completion Date
    June 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    South Valley University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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).
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ovarian Failure
    Keywords
    Premature, Ovarian, Failure, Filgrastim

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Filgrastim arm
    Arm Type
    Active Comparator
    Arm Description
    Intervention: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days
    Arm Title
    Placebo arm
    Arm Type
    Placebo Comparator
    Arm Description
    Intervention: Injection of saline SC injection twice daily for five consecutive days.
    Intervention Type
    Biological
    Intervention Name(s)
    Filgrastim
    Other Intervention Name(s)
    Granulocyte-Colony Stimulating Factor (G-CSF)
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Other Intervention Name(s)
    placebo
    Intervention Description
    Injection of saline SC injection twice daily for five consecutive days
    Primary Outcome Measure Information:
    Title
    Return of menses
    Description
    Return of menses in patients with amenorrhea of at least 4 months
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Pregnancy
    Description
    Occurrence of pregnancy as diagnosed by positive serum B-hCG and/or ultrasound
    Time Frame
    6 months
    Title
    serum Estradiol
    Description
    Normalization of serum Estradiol as tested bi-weekly
    Time Frame
    6 months
    Title
    serum Anti-mullarian Hormone (AMH)
    Description
    Normalization of serum AMH in patients with AMH level less than 0.9 ng/mL
    Time Frame
    6 months
    Title
    serum FSH
    Description
    Normalization of serum FSH in patients with FSH level above 25 IU/L
    Time Frame
    6 months
    Title
    Follicular growth
    Description
    Growth of follicle to size at least 18 mm as monitored by transvaginal ultrasound
    Time Frame
    6 months
    Title
    endometrial thickness
    Description
    increase of endometrial thickness in women with thin endometrium (less then 8 mm)
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad AM Ahmed, MD
    Organizational Affiliation
    Egypt, Qena, South Valley University, faculty of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23453120
    Citation
    Skaznik-Wikiel ME, McGuire MM, Sukhwani M, Donohue J, Chu T, Krivak TC, Rajkovic A, Orwig KE. Granulocyte colony-stimulating factor with or without stem cell factor extends time to premature ovarian insufficiency in female mice treated with alkylating chemotherapy. Fertil Steril. 2013 Jun;99(7):2045-54.e3. doi: 10.1016/j.fertnstert.2013.01.135. Epub 2013 Feb 26.
    Results Reference
    background
    PubMed Identifier
    25142624
    Citation
    Akdemir A, Zeybek B, Akman L, Ergenoglu AM, Yeniel AO, Erbas O, Yavasoglu A, Terek MC, Taskiran D. Granulocyte-colony stimulating factor decreases the extent of ovarian damage caused by cisplatin in an experimental rat model. J Gynecol Oncol. 2014 Oct;25(4):328-33. doi: 10.3802/jgo.2014.25.4.328. Epub 2014 Jun 18.
    Results Reference
    background
    PubMed Identifier
    25439845
    Citation
    Benavides-Garcia R, Joachim R, Pina NA, Mutoji KN, Reilly MA, Hermann BP. Granulocyte colony-stimulating factor prevents loss of spermatogenesis after sterilizing busulfan chemotherapy. Fertil Steril. 2015 Jan;103(1):270-80.e8. doi: 10.1016/j.fertnstert.2014.09.023. Epub 2014 Nov 5.
    Results Reference
    background
    PubMed Identifier
    26576728
    Citation
    Bhartiya D, Anand S, Parte S. VSELs may obviate cryobanking of gonadal tissue in cancer patients for fertility preservation. J Ovarian Res. 2015 Nov 17;8:75. doi: 10.1186/s13048-015-0199-2.
    Results Reference
    background
    PubMed Identifier
    24833728
    Citation
    Roness H, Kalich-Philosoph L, Meirow D. Prevention of chemotherapy-induced ovarian damage: possible roles for hormonal and non-hormonal attenuating agents. Hum Reprod Update. 2014 Sep-Oct;20(5):759-74. doi: 10.1093/humupd/dmu019. Epub 2014 May 15.
    Results Reference
    background

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    Filgrastim for Premature Ovarian Insufficiency

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