- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06302543
Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells (alfarah)
Treatment of Premature Ovarian Insufficiency Using Autologous Bone Marrow Concentrates Through Transvaginal Approach Under Ultrasound Guidance
investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.
Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Premature ovarian insufficiency is a clinical syndrome characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotrophin hormones and low estrogen and anti-Mullerian hormone. The average age for menopause is 50-52 years in the developed world ,it is believed that about 1% for women less than 40 years of age and 0.1 in less than 30 years of age has premature ovarian insufficiency.
Etiology of POI may be genetic, chromosomal, or auto immune.in addition to cancer treatment and surgical causes.
Hormonal replacement therapy is recommended for POI patients to alleviate vasomotor symptoms in addition to prevent osteoporosis and ischemic heart disease.
Regenerative medicine is a new medical approach to treat variety of diseases involving many tissues or organs in human body using cells, biological products instead of drugs or physical factors.
Autologous use of stem cells from bone marrow or adipose tissue (stromal vascular fraction) or platelet rich plasma are alternative safe minimal manipulative products that can provide a solution to this clinical syndrome.
Only few cases had been mentioned in the literature offering autologous stem cells for treating POI including bone marrow or adipose derived stem cells in addition to mesenchymal stem cells expanded invitro.
the investigator use autologous bone marrow concentrate with transvaginal approach under ultrasound guidance to treat POI.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: abdulmajeed hammadi, MD
- Phone Number: +9647902268105
- Email: majeed51578@yahoo.co.uk
Study Contact Backup
- Name: bushra alazzawi, MD
- Phone Number: +9647705851195
- Email: khaliljumakareem69@gmail.com
Study Locations
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-
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Baghdad, Iraq, 964
- Recruiting
- Ministry of Health
-
Contact:
- abdulmajeed Hammadi, MD
- Phone Number: +9647902268105
- Email: alzaitounhospital@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- clinical diagnosis of premature Ovarian insufficiency.
- ineffective hormonal therapy.
- biochemical evidence of high gonadotropins.
Exclusion criteria:
- solid or hematological malignancies.
- bleeding disorders.
- rejection of the procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bone marrow
autologous bone marrow derived mononuclear cells injected 1cc per ovary for 2 ovaries under general anesthesia under ultrasound guide
|
under general anesthesia bone marrow aspiration done followed by cell concentration and transvaginal ovarian injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in gonadotropin levels
Time Frame: check every 4 weeks through study completion, an average of 1 year".
|
luteinizing hormone and follicular stimulating hormone are followed
|
check every 4 weeks through study completion, an average of 1 year".
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Premature Birth
- Primary Ovarian Insufficiency
- Menopause, Premature
Other Study ID Numbers
- POI bone marrow
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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