Exosome therapy in infertility

Phase 1

Recruiting

Conditions: Diminished ovarian reserve.
Female infertility associated with anovulation
N97.0

Registration Number: IRCT20210228050535N1

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 30

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.