Premature Ovarian InsufficiencyalfarahNCT06302543
Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells
A study testing autologous bone marrow cells injection in people with Premature Ovarian Insufficiency, run by abdulmajeed hammadi at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- autologous bone marrow cells injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2024to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- clinical diagnosis of premature Ovarian insufficiency.
- ineffective hormonal therapy.
- biochemical evidence of high gonadotropins.
Who cannot join
- solid or hematological malignancies.
- bleeding disorders.
- rejection of the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- autologous bone marrow cells injection
- Keywords
- premature ovarian failure,bone marrow,treatment
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow cells injectionProcedure or surgery
under general anesthesia bone marrow aspiration done followed by cell concentration and transvaginal ovarian injection
| Study group | Role | What they receive |
|---|---|---|
| bone marrow | Experimental | autologous bone marrow derived mononuclear cells injected 1cc per ovary for 2 ovaries under general anesthesia under ultrasound guide Receives: Procedure: autologous bone marrow cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in gonadotropin levels
luteinizing hormone and follicular stimulating hormone are followed
Measured: check every 4 weeks through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2024
- Primary completion10 Mar 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single armed interventional study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- abdulmajeed hammadi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, abdulmajeed hammadi, Global Stem Cell Center, Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302543
- Sponsor's protocol ID
- POI bone marrow
- Other IDs
- alfarah fertility center
- Acronym
- alfarah
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Premature Ovarian Insufficiency Using Autologous Bone Marrow Concentrates Through Transvaginal Approach Under Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT06302543
- Acronym / sponsor ID
- alfarah / POI bone marrow
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- premature ovarian failure,bone marrow,treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- abdulmajeed hammadiIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single armed interventional study
| Arm | Type | Receives |
|---|---|---|
| bone marrow | Experimental | Procedure: autologous bone marrow cells injectionautologous bone marrow derived mononuclear cells injected 1cc per ovary for 2 ovaries under general anesthesia under ultrasound guide |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- clinical diagnosis of premature Ovarian insufficiency.
- ineffective hormonal therapy.
- biochemical evidence of high gonadotropins.
Key exclusion criteria (3 listed)
- solid or hematological malignancies.
- bleeding disorders.
- rejection of the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous bone marrow cells injectionunder general anesthesia bone marrow aspiration done followed by cell concentration and transvaginal ovarian injection | Procedure or surgery | bone marrow |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous bone marrow cells injection in people with Premature Ovarian Insufficiency, run by abdulmajeed hammadi at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in gonadotropin levels (time frame: check every 4 weeks through study completion, an average of 1 year".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.