Effectiveness evaluation of intra-ovarian injection of autologous menstrual blood stem cells in fertility potential of patients with poor ovarian response: a controlled clinical trial study

Phase 3

Recruiting

• Conditions: Poor ovarian response.; Asymptomatic postprocedural ovarian failure; E89.40

• Registration Number: IRCT20180619040147N4
• Lead Sponsor: Iranian academic center for education culture and research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

married women
ages between 25-45 years old
Picked up equal or less than 3 oocytes in last ovarian stimulation
Anti mullerian hormone; less than 1.1 nanogram per milliliter
Anteral follicles: less than 5-7
Spermogram: more than 5 million per millilieter
normal morphology more than 1%

Exclusion Criteria

un treated 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
renal failure disease
history of blood trasfusion, anemia or sickle cell anemia

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber 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 Outcome Measures

Name	Time	Method
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.