Evaluation and comparison of the safety and effectiveness of Intra uterine injection of autologous menstrual blood-derived stem cells (MenSCs) and PRP in unfertilized women with thin unfunctional endometrium

Phase 1

Recruiting

• Conditions: thin endometrium.; Abnormal findings on diagnostic imaging of urinary organs; R93.4

• Registration Number: IRCT20180619040147N3
• 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: 15 June 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

married women
under 7 mm thickness of endometrium
showing 3-4 Appelbaum classification of endometrium tissue pattern
minimum or no blood supply of zone 3 of endometrium
score 1-0 of arterial blood flow into endometrium
intrauterine adhesions
a history of no responding to routine treatment for this issue
having at least 2 high quality embryos in freeze cycle
ages between 25-40

Exclusion Criteria

Thyroid disfunction
Immune disorders
history of cancer, chemotherapy and radiotherapy
hepatitis B, C and HIV infections
severe endometriosis
diabetes
Dysfunction of electrolyte or liver tests

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endometrium thickness. Timepoint: 1, 2 and 3rd month after injection. Method of measurement: Vaginal sonography.;Uterine arterial blood flow. Timepoint: 1, 2 and 3rd month after injection. Method of measurement: Vaginal sonography.;Blood flow precence into zone 3 of the endometrium. Timepoint: 1, 2 and 3rd month after injection. Method of measurement: vaginal sonography.;Endomtrial tissue pattern. Timepoint: 1, 2 and 3rd month after injection. Method of measurement: vaginal sonography.

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.