Phase I Study of Role of Stem Cells in Improving Implantation Rates in ICSI Patients
20 Years
40 Years
Female
Assess the Efficacy of Differentiated and Undifferentiated Stem Cell Therapy in Improving Endometrial Receptivity.
Trial Information
Phase I Study of Role of Stem Cells in Improving Implantation Rates in ICSI Patients
Inclusion Criteria:
- ICSI candidates with repeated implantation failure and history of development of good
embryos in previous ICSI cycles.
- Advanced maternal age above 38 years.
- Poor endometrial response to ovulation induction drugs.
- Endometrial atrophy.
Exclusion Criteria:
- Presence of infection in the form of vaginitis, cervicitis or hydrosalpinx.
- Presence of uterine abnormality as uterine septum.
- Presence of any pathology distorting the uterine cavity as:
submucus polyp or submucus myoma.
- Marked sperm morphology abnormality.
- High FSH > 12 IU.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Implantation rate
Outcome Description:
Comparison of the implantation rates of all groups; the differentiated stem cell group, the undifferentiated stem cell group and the control group to assess the efficacy of differentiated and undifferentiated stem cell therapy in improving endometrial receptivity.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Nawara Mohamed Hashish, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistant Professor of Gynecology and Obstetrics
Authority:
Egypt: Ministry of Health and Population
Study ID:
Stem cells and implantation
NCT ID:
NCT01649752
Start Date:
September 2012
Completion Date:
March 2013
Related Keywords:
- Assess the Efficacy of Differentiated and Undifferentiated Stem Cell Therapy in Improving Endometrial Receptivity.
- Stem cells
- Uterine cavity
- Implantation
- ICSI
- Adenoma
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