Actively Recruiting
Treatment of Premature Ovarian Insufficiency Using Autologous Bone Marrow Concentrates Through Transvaginal Approach Under Ultrasound Guidance
Led by abdulmajeed hammadi · Updated on 2025-08-05
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment for premature ovarian insufficiency, a condition where ovarian function declines early in women under 40 years old. This condition is marked by irregular or absent menstruation and hormonal changes such as increased gonadotropins and decreased estrogen and anti-Mullerian hormone. The study investigates the use of autologous bone marrow-derived mononuclear cells to potentially restore ovarian function without needing an oocyte donation program. The treatment involves collecting bone marrow cells from the participant under general anesthesia, concentrating these cells, and then injecting 1cc of the concentrated mononuclear cells into each ovary using a transvaginal approach guided by ultrasound. This is a single-arm interventional study where all participants receive this procedure performed by an experienced gynecologist. Participants will be monitored every four weeks for about one year to assess changes in gonadotropin hormone levels as the primary outcome. The study also involves ultrasound assessments to observe ovarian follicle development and laboratory tests for hormonal studies. The overall goal is to evaluate the safety and biological effects of the bone marrow cell injections in women diagnosed with premature ovarian insufficiency.
CONDITIONS
Brief Title
Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of premature ovarian insufficiency
- Ineffective hormonal therapy
- Biochemical evidence of high gonadotropin levels
- Female participants aged 30 to 60 years
You will not qualify if you...
- Presence of solid or blood cancers
- Bleeding disorders
- Refusal to undergo the procedure or rejection of the procedure itself
- Male participants or females outside the age range of 30 to 60 years (implied by gender and age criteria)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up
Participants receive an autologous bone marrow cell injection under general anesthesia using a transvaginal ultrasound-guided approach to treat premature ovarian insufficiency.
1 treatment visit (in-person)
Duration - Approximately 1 year
Participants are monitored with hormonal level assessments every 4 weeks to evaluate treatment effects for up to approximately 1 year.
Monthly visits for hormone level checks
Trial Site Locations
Total: 1 location
1
Ministry of Health
Baghdad, Iraq, 964
Actively Recruiting
Research Team
A
abdulmajeed hammadi, MD
B
bushra alazzawi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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