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

Not Applicable

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

• Registration Number: CTRI/2020/01/022726
• Lead Sponsor: AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 < 5, AMH < 1.2ng/ml and/or high FSH ( >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

1.Past or present evidence of gynecological malignancy

2.Type 1 or II Diabetes Mellitus

3.Presence of anemia ( Hb < 8 g/dl)

4.Contraindications of bone marrow harvesting as per departmental protocol

5.Acquired poor ovarian reserve (Chemotherapy, radiotherapy)

6.Ovarian endometriosis

7.Prior ovarian surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a.Improved diagnostic hormonal levels ( FSH , AMH , Estradiol) <br/ ><br>b.Improved USG parameters- increase in AFC <br/ ><br>Timepoint: 1, 3 and 6 months after stem cell infusion <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>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 . <br/ ><br>Timepoint: a. 16 days after embryo transfer <br/ ><br>b. 6 weeks if pregnancy