Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells

NCT06302543 | Recruiting DMC

• 1 other identifier: POI bone marrow
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Ovarian Insufficiency

Keywords

premature ovarian failure,bone marrow,treatment

Outcome Measures

Primary Outcomes (1)

• change in gonadotropin levels

  luteinizing hormone and follicular stimulating hormone are followed

  check every 4 weeks through study completion, an average of 1 year".

Study Arms (1)

bone marrow

EXPERIMENTAL

autologous bone marrow derived mononuclear cells injected 1cc per ovary for 2 ovaries under general anesthesia under ultrasound guide

Procedure: autologous bone marrow cells injection

Interventions

autologous bone marrow cells injection PROCEDURE

under general anesthesia bone marrow aspiration done followed by cell concentration and transvaginal ovarian injection

bone marrow

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: mainly related to females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• clinical diagnosis of premature Ovarian insufficiency.
• ineffective hormonal therapy.
• biochemical evidence of high gonadotropins.

You may not qualify if:

• solid or hematological malignancies.
• bleeding disorders.
• rejection of the procedure.

Sponsors & Collaborators

• abdulmajeed hammadi: lead

Study Sites (1)

Ministry of Health

Baghdad, 964, Iraq

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

abdulmajeed hammadi, MD

CONTACT

+9647902268105; majeed51578@yahoo.co.uk

bushra alazzawi, MD

CONTACT

+9647705851195; khaliljumakareem69@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical professor

Model Details: single armed interventional study

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)