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Trial record 31 of 32 for:    stem cell Spinal Cord Injury AND mesenchymal stem cells

Role of Stem Cells in Improving Implantation Rates in ICSI Patients

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ClinicalTrials.gov Identifier: NCT01649752
Recruitment Status : Unknown
Verified July 2012 by Nawara Mohamed Hashish, Kasr El Aini Hospital.
Recruitment status was:  Recruiting
First Posted : July 25, 2012
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Nawara Mohamed Hashish, Kasr El Aini Hospital

Tracking Information
First Submitted Date  ICMJE July 23, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date June 30, 2015
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Implantation rate [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01649752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Endometrial volume and vascularity [ Time Frame: 6 months ]
Doppler study of the endometrial blood flow; the VI, FI and VFI and 3D-US assessment of endometrial volume in all groups at the day of embryo transfer to obtain objective assessment of the effect of differentiated and undifferentiated stem cell therapy on endometrial volume and vascularity in ICSI patients with advanced maternal age or history of repeated implantation failure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Stem Cells in Improving Implantation Rates in ICSI Patients
Official Title  ICMJE Phase I Study of Role of Stem Cells in Improving Implantation Rates in ICSI Patients
Brief Summary

Background:

Improving implantation rates in ICSI cycles has been the focus of research in recent decades. Because success rates is not satisfactory enough especially when transferring good embryos to the uterine cavity and pregnancy does not occur. Trying to improve endometrial receptivity, the investigators have thought about stem cell therapy as stem cells have played a pivotal role in regenerative medicine in many pathologies as myocardial infarction, Diabetes Mellitus and spinal cord injuries.

Garget and Healy reported in 2011 treatment of a case with Asherman's syndrome by administration of bone marrow stem cells in the uterine cavity. Endometrial growth and improved vascularity has been observed by ultrasound follow-up and Doppler study of endometrial blood flow. Endometrial regeneration has been enough to support pregnancy through successful IVF trial.

The investigators have succeeded in previous work to isolate MSC from placental tissue and differentiate it to endometrium-like cells. The investigators compared the differentiation ability of placental derived mesenchymal stem cells (MSC) and Wharton Jelly derived MSC to differentiate to endometrium under 3 different culture conditions: endometrium conditioned medium (ECM), follicular fluid (FF) conditioned medium and medium containing both. The investigators found that placental MSC has better differentiating ability to endometrium especially under culture conditions containing both ECM and FF as evidenced by prominent appearance of glandular pattern and expression of progesterone receptors in differentiated cells.

Therefore the investigators need to direct this study and test the effect of placental derived MSC in improving implantation rates in patients with recurrent implantation failure, unresponsive endometrium to ovulation induction drugs or with endometrial atrophy or advanced maternal age planning for ICSI trial.

Patients and Methods:

60 patients attending Kasr El-Aini assisted reproduction unit and private IVF center will be randomized to three groups by computer generated programs:

The first group, patients randomized to receive differentiated stem cell therapy:

After ovum pick-up, MSC differentiated to endometrium is deposited in the uterine cavity through an IUI catheter. Embryo transfer will be done at day 5 at the blastocyst stage to allow enough time for endometrial regeneration and increased endometrial receptivity.

The second group, patients randomized to receive undifferentiated stem cell therapy:

Immediately postmenstrual undifferentiated MSC is deposited in the uterine cavity through an IUI catheter to allow enough time for the MSC to differentiate as it needs 7-10 days for differentiation. Ovum pick-up will be done as usual while all other steps will be the same including embryo transfer which will be done at day 5.

The third group, control group:

Patients are randomized to receive no stem cell therapy; All ICSI steps from ovulation induction protocol to embryo transfer conditions will be the same for all groups.

Informed consent will be taken from the patients after detailed explanation of all steps of the procedure.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Assess the Efficacy of Differentiated and Undifferentiated Stem Cell Therapy in Improving Endometrial Receptivity.
Intervention  ICMJE
  • Biological: Differentiated stem cells to endometrium is deposited in the uterine cavity through an IUI catheter
  • Biological: Undifferentiated MSC is deposited in the uterine cavity through an IUI catheter.
Study Arms  ICMJE
  • Experimental: Differentiated stem cell therapy group
    After ovum pick-up, MSC differentiated to endometrium is deposited in the uterine cavity.Embryo transfer will be done at day 5 at the blastocyst stage.
    Intervention: Biological: Differentiated stem cells to endometrium is deposited in the uterine cavity through an IUI catheter
  • Experimental: undifferentiated stem cell therapy group
    Immediately postmenstrual undifferentiated MSC is deposited in the uterine cavity. Ovum pick-up will be done as usual.Embryo transfer will be done at day 5 at the blastocyst stage.
    Intervention: Biological: Undifferentiated MSC is deposited in the uterine cavity through an IUI catheter.
  • No Intervention: Control group
    ovum pick-up as usual and embryo transfer at day 5 at the blastocyst stage.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 24, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649752
Other Study ID Numbers  ICMJE Stem cells and implantation
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nawara Mohamed Hashish, Kasr El Aini Hospital
Study Sponsor  ICMJE Kasr El Aini Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nawara Mohamed Hashish, MD Assistant Professor of Gynecology and Obstetrics
PRS Account Kasr El Aini Hospital
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP