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Exosome therapy in infertility

Evaluation of effect of the autologous exosomes derived from menstrual blood mesenchymal cells on the ovarian reserve follicles and the rate of pregnancy in patients with Diminished Ovarian Reserve (DOR)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210228050535N1
Enrollment
30
Registered
2022-02-27
Start date
2022-02-04
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

Diminished ovarian reserve. Female infertility associated with anovulation

Interventions

Intervention 1: Intervention group: 5 mililiter of menstrual blood sample will be collected from patients with menstrual cup. Mesenchymal cells will be isolated and cultured from a menstrual blood sam

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 42 Years

Inclusion criteria

Inclusion criteria: Patients aged 20-42 Years Body mass index (BMI) below 30 (kilograms per square meters) Diagnosed diminished ovarian reserve (DOR) Antral follicles below 7 Anti Mullerian Hormone (AMH) below 1.1 nanogram per mililiter (ng/ml) Premature ovarian insufficiency (POI) Unovulation or amnehorreha

Exclusion criteria

Exclusion criteria: Abnormal shape of the uterus on Hysterosalpingography (HSG) or hysteroscopy Hematologic or immunologic diseases Hormonal disturbances Chromosomal and genetics abnormalities Pregnant patients Obstruction of fallopian tubes on Hysterosalpingography or laparoscopy Patients affected by Thyroid disease Patients affected by diabetes Chronic malignancies Chronic pelvic pain Infertility due to severe male factor

Design outcomes

Primary

MeasureTime frame
Estradiol rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: ELISA diagnostic kit.;The ovarian follicle growth rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: Ultrasound.;Oocyte quality rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: Oocyte classification based on presence or absence of polar body and nucleolus.;Follicle Stimulating Hormone (FSH) rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: ELISA diagnostic kit.;Anti Mullerian Hormone (AMH) rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: ELISA diagnostic kit.

Secondary

MeasureTime frame
Pregnancy rate. Timepoint: 1 to 3 months after injection and 12 weeks after pregnancy. Method of measurement: Beta-Human Chorionic Gonadotropin(B HCG) test, Ultrasound.;Live newborn birth rate. Timepoint: 9 to 12 months after injection. Method of measurement: Follow up.;Abortion rate. Timepoint: 1 to 9 month after pregnancy. Method of measurement: Ultrasound, follow up.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShabanali Khodashenas Limoni

Mazandaran University of Medical Sciences

s.khodashenas@mazums.ac.ir+98 11 3311 8945

Outcome results

None listed

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