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Evaluation of the effect of menstrual blood stem cells in recurrent pregnancy loss

Phase 1
Conditions
Recurrent pregnancy loss.
Pregnancy, childbirth and the puerperium
Registration Number
IRCT20210513051280N2
Lead Sponsor
Iranian academic center for education culture and research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Female
Target Recruitment
40
Inclusion Criteria

Women with primary recurrent pregnancy losses (at least two successive pregnancy losses excluding blighted ovum confirmed by sonography or pathology till 10th week of gestation
Maximum patient age: 37 years, no history of previous live birth
FSH level of less than 10 mIU/mL
Negative test results for HIV, HBS Ag, HCV and VDR

Exclusion Criteria

Having previous history of successful pregnancy
Chromosomal abnormalities in parents
Uterine anatomic abnormalities
Hormonal abnormalities
PCO with metabolic syndrome
Uncontrolled diabetes
Stage 3 or 4 endometriosis
Autoimmune diseases including rheumatoid arthritis, thyroid autoimmunity, lupus and anti-phospholipid antibodies
History of cancer, chemotherapy and radiotherapy
Spermogram abnormalities (DFI more than 30 and normal sperm morphology less than 2%
History of immunosuppressive drugs intake including corticosteroids during the past three months

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pregnancy loss. Timepoint: Before 20th week of gestation. Method of measurement: Sonography.
Secondary Outcome Measures
NameTimeMethod
Clinical pregnancy rate. Timepoint: 6th week of pregnancy. Method of measurement: Sonography.;Live birth rate. Timepoint: At the end of pregnancy period. Method of measurement: Delivery.;Twin pregnancy. Timepoint: 6th week of gestation. Method of measurement: Sonography.;Newborn weight. Timepoint: After delivery. Method of measurement: Weighting.
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