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Evaluation of the safety and feasibility of intra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.

Evaluation of the safety and feasibility of intra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180619040147N2
Enrollment
36
Registered
2018-08-21
Start date
2018-08-06
Completion date
Unknown
Last updated
2020-04-21

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

Conditions

Poor ovarian response. Asymptomatic postprocedural ovarian failure

Interventions

Intervention 1: Intervention group: includes 18 patients with poor ovarian response that will be treated by once injection of autologous menstrual blood stem cells. After cells isolation, culture and

Sponsors

Iranian Academic Center for Education Culture and Research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: Got married woman Picked up less than 3 oocytes in last ovarian stimulation Anti mullerian hormone; less than 1.1 ng/ml Upper age limit: 40 Spermogram: more than 5 million/ml, normal morphology more than 1, sperm motility (A+B) more than 25% Anteral follicles: less than 5-7

Exclusion criteria

Exclusion criteria: Thyroid dysfunction Immune disorders History of cancer, chemotherapy and radiotherapy Infected by hepatitis B,C or HIV Severe endometriosis History of ovarian surgery Diabetes Dysfunction of electrolyte or liver tests Psychological problem like depression, high stress an anxiety

Design outcomes

Primary

MeasureTime frame
Number of antral follicles in ovary. Timepoint: Before intervention, 3 months and 6 months after cell administration. Method of measurement: Vaginal sonography.;Anti Mullerian hormone level in blood serum. Timepoint: Before intervention, 3 months, 6 months and one year after cell administration. Method of measurement: biochemical assay.;Number and quality of oocytes in intra-cytoplasmic sperm injection cycle. Timepoint: first intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: embryologic evaluation.;Spontaneous pregnancy. Timepoint: up to 3 months after intervention. Method of measurement: beta-HCG assay.

Secondary

MeasureTime frame
Implantation rate. Timepoint: in new intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: Vaginal sonography.;Clinical pregnancy. Timepoint: 6-8 weeks after last menstrual period. Method of measurement: Vaginal sonography.;Live birth. Timepoint: 9 months after pregnancy. Method of measurement: delivery report based on gynecologist comment.;Embryo quality and number. Timepoint: in new intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: embryology report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomaieh Kazemnejad

Iranian Academic Center for Education Culture and Research

kazemnejad_s@yahoo.com+98 21 2243 2020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 26, 2026