Filgrastim for Premature Ovarian Insufficiency (FIL-POI)

September 20, 2021 updated by: Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University

Filgrastim for Treatment of Premature Ovarian Insufficiency: Randomized Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return of menses
Time Frame: 6 months
Return of menses in patients with amenorrhea of at least 4 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy
Time Frame: 6 months
Occurrence of pregnancy as diagnosed by positive serum B-hCG and/or ultrasound
6 months
serum Estradiol
Time Frame: 6 months
Normalization of serum Estradiol as tested bi-weekly
6 months
serum Anti-mullarian Hormone (AMH)
Time Frame: 6 months
Normalization of serum AMH in patients with AMH level less than 0.9 ng/mL
6 months
serum FSH
Time Frame: 6 months
Normalization of serum FSH in patients with FSH level above 25 IU/L
6 months
Follicular growth
Time Frame: 6 months
Growth of follicle to size at least 18 mm as monitored by transvaginal ultrasound
6 months
endometrial thickness
Time Frame: 6 months
increase of endometrial thickness in women with thin endometrium (less then 8 mm)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Principal Investigator: Mohammad AM Ahmed, MD, Egypt, Qena, South Valley University, faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBGYN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Ovarian Failure

Clinical Trials on Filgrastim

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe