Effect of cell therapy in premature ovarian failure

Phase 2

Conditions: Primary ovarian failure.
Primary ovarian failure
E28.3

Registration Number: IRCT20210612051545N7

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 35

Inclusion Criteria

Have established regular menstrual cycle, oligomenorrhea / amenorrhea = 4 months
FSH (Follicle-Stimulating Hormone) > 25 IU/mL
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The duration of amenorrhea is less than 3 years
The average diameter of the ovary is above 10 mm

Exclusion Criteria

Primary amenorrhea
Thyroid dysfunction, TSH > 0.4 L/mIU
Serious systemic diseases, cardiovascular, liver, kidney, blood system and all uncontrolled chronic diseases (diabetes, …)
Pregnancy contraindications
History of PID, endometriosis, ovarian cyst surgery, uterine myoma
History of cancer, chemotherapy, radiation therapy
Congenital abnormalities of the reproductive system
Autoimmune diseases such as MS, SLE
Spouse with sperm count less than 10 ml/m, and normal sperm shape less than 4%
Smoking
Positive viral tests for HCV, HBS, HIV,

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of side effects, including short-term and long-term, systemic or local side effects and severe or mild side effects. Timepoint: first 24 hours, 1st and 2nd week, 1st, 2nd, 3rd, 4th, 5th, 6th month after injection. Method of measurement: clinical examinations and laboratory tests.

Secondary Outcome Measures

Name	Time	Method
Correction of hormonal status such as reduction of FSH level. Timepoint: First 24 hours, week 1 and 2, month 1, 2, 3, 4, 5, 6 after injection. Method of measurement: laboratory tests.