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Exosome therapy for premature ovarian failure patients

Using exosomes as a new therapeutic method for patients with premature ovarian failure

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251013067610N1
Enrollment
10
Registered
2025-11-10
Start date
2026-04-04
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Premature ovarian insufficiency. Female infertility

Interventions

Intervention group: Exosome-administrated patients.

Sponsors

PerciaVista
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 40 Years

Inclusion criteria

Inclusion criteria: Post-menarche female less than 40 years old Primary or secondary amenorrhea at least for 3-6 months Diagnosis of premature ovarian failure or insufficiency: At least two menopausal FSH levels (= 20 IU/L) Clinical diagnosis of Premature Ovarian Failure AMH10 million sperms/ml).

Exclusion criteria

Exclusion criteria: Abnormal physical conditions Diagnosed with autoimmune diseases Patients with congenital ovarian malformations Patients with severe endometriosis Patients with pregnancy contraindications Diagnosed with thyroid dysfunction Past history of malignancy/chemotherapy/radiotherapy Infectious diseases: HIV+, hepatitis B+, C+ Diagnosed with abnormal karyotype Previous surgical management of ovarian pathology Enrollment in other trials in the last 3 months Presence of adnexal masses or tenderness indicating the need for further evaluation Major mental health disorder that precludes participation in the study Active substance abuse or dependence Current or recent (within the past 3 months) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, Herbal or botanical supplements with possible hormonal effects Type I or Type II diabetes mellitus or if receiving anti-diabetic medications Hb <11 g/dL, platelets <150,000/mm3 Patient with bleeding diathesis Use of NSAIDs in the 10 days before procedure

Design outcomes

Primary

MeasureTime frame
Improving ovarian follicular population. Timepoint: Periodic examinations for up to 12 months will be performed to check the repair of ovarian tissue in terms of follicular growth and development using ultrasound and changes in serum levels of sex hormones on a monthly basis. Method of measurement: Ultrasound images.;Regulating blood levels of sex hormones such as FSH, LH, E2, AMH. Timepoint: Periodic examinations for up to 12 months will be performed to check the repair of ovarian tissue in terms of follicular growth and development using ultrasound and changes in serum levels of sex hormones on a monthly basis. Method of measurement: Sex hormone level results.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Mahdipour

Tabriz University of Medical Sciences

Mahdi.mahdipour@gmail.com+98 41 3336 3870

Outcome results

None listed

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