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To study the effect of infusion of stem cells derived from own bone marrow into the ovaries in cases of early onset of depletion of ovarian follicles

To evaluate the role of Autologous Bone Marrow derived Stem Cell Transplantation for Premature Ovarian Ageing - TAMSCOT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022726
Enrollment
50
Registered
2020-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O090- Supervision of pregnancy with history of infertility

Interventions

Intervention1: Bone Marrow derived Stem Cells: 30 ml bone marrow aspirated and mononuclear cells will be isolated and tagged with antobody followed by flow cytometry assessment of the cells.2ml stem c

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 20-38 years 2. Normal karyotype 3. Adequate uterine cavity either by imaging or hysteroscopically 4. Normal thyroid function tests 5. Diagnosis of premature ovarian failure by FSH > 25IU/l, and/or primary or secondary amenorrhea at least for 4 months 6. Diminished ovarian reserve - AFC 8 IU/l) 7. No other cause of female infertility 8. Normal autoimmune work up â?? anti TPO, FBS(R/O IDDM),Complete blood count (R/O ITP, Hemolytic anemia), Anti nuclear antibodies (R/O SLE)

Exclusion criteria

Exclusion criteria: 1. Past or present evidence of gynecological malignancy 2. Type 1 or II Diabetes Mellitus 3. Presence of anemia ( Hb 4. Contraindications of bone marrow harvesting as per departmental protocol 5. Acquired poor ovarian reserve (Chemotherapy, radiotherapy) 6. Ovarian endometriosis 7. Prior ovarian surgery

Design outcomes

Primary

MeasureTime frame
a. Improved diagnostic hormonal levels ( FSH , AMH , Estradiol) b. Improved USG parameters- increase in AFC Timepoint: 1, 3 and 6 months after stem cell infusion

Secondary

MeasureTime frame
a. Spontaneous or after Controlled ovarian hyperstimulation (COH) : Biochemical Pregnancy Rate â?? Defined as serum β-hCG value of more than 100IU detected 16 days after embryo transfer. b. Spontaneous or after COH: Clinical pregnancy rate â?? Defined as evidence of pregnancy by visualization of intrauterine gestation sac and embryonic pole with heartbeat on ultrasound performed 6 weeks after embryo transfer . Timepoint: a. 16 days after embryo transfer b. 6 weeks if pregnancy

Countries

India

Contacts

Public ContactYogita Dogra

All India Institute of Medical Sciences

dryogitadogra@gmail.com7018955300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026