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

Assessment of safety and effectiveness of intrauterine infusion of allogeneic menstrual blood stem cells in women with unexplained recurrent pregnancy loss: A double-blind phase 1 and 2 clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210513051280N2

Enrollment

Registered

2021-05-31

Start date

2021-07-21

Completion date

Unknown

Last updated

2021-06-21

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

Conditions

Recurrent pregnancy loss. Pregnancy, childbirth and the puerperium

Interventions

Intervention 1: Intervention group: A single dose of intrauterine infusion of allogeneic decidualized menstrual blood stem cells with final volume of 0.5 ml containing 1 million cells. Intervention 2

Eligibility

Sex/Gender

Female

Age

20 Years to 37 Years

Inclusion criteria

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 VDRL

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Pregnancy loss. Timepoint: Before 20th week of gestation. Method of measurement: Sonography.	—

Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir-Hassan Zarnani

Iranian academic center for education culture and research

zarnania@gmail.com+98 21 2243 2020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026