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Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)

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ClinicalTrials.gov Identifier: NCT03033277
Recruitment Status : Unknown
Verified January 2017 by Hongmei Wang, Chinese Academy of Sciences.
Recruitment status was:  Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
The Third Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Hongmei Wang, Chinese Academy of Sciences

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date January 26, 2017
Actual Study Start Date  ICMJE February 2016
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Number of mature follicle [ Time Frame: Up to 4 months ]
The number of mature follicles developing was recorded by transvaginal ultrasound scan
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Follicle-stimulating hormone (FSH) serum level [ Time Frame: Up to 4 months ]
    Serum FSH level was evaluated once a month after surgery
  • Estradiol (E2) serum level [ Time Frame: Up to 4 months ]
    Serum E2 level was evaluated once a month after surgery
  • Anti-Mullerian hormone (AMH) serum level [ Time Frame: Up to 4 months ]
    Serum AMH level was evaluated once a month after surgery
  • Number of antral follicle development [ Time Frame: Up to 4 months ]
    The number of antral follicles developing was recorded by transvaginal ultrasound scan
  • Ovarian volume [ Time Frame: Up to 4 months ]
    The ovarian volume was recorded by transvaginal ultrasound scan
  • Pregnancy rate [ Time Frame: Up to 12 months ]
    The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.
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 Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
Official Title  ICMJE Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
Brief Summary There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Ovarian Insufficiency
Intervention  ICMJE
  • Biological: Placebo transplantation
    Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
  • Biological: HUC-MSCs transplantation
    Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.
Study Arms  ICMJE
  • Placebo Comparator: Control group
    Hormone replacement therapy, placebo transplantation.
    Intervention: Biological: Placebo transplantation
  • Experimental: Experimental group
    Hormone replacement therapy,HUC-MSCs transplantation.
    Intervention: Biological: HUC-MSCs transplantation
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: January 24, 2017)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosed with primary ovarian insufficiency;
  2. Women between 20 and 40 years;
  3. Have fertility requirements, husband has sperm;
  4. Willing to sign the Informed Consent Form.

Exclusion Criteria:

  1. Primary amenorrhea;
  2. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
  3. Thyroid dysfunction;
  4. Severe endometriosis;
  5. Contraindications for pregnancy;
  6. Prior personal history of ovarian cancer;
  7. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
  8. History of serious drug allergy or allergic constitution;
  9. Autoimmune disease, history of severe familial genetic disease;
  10. HIV+, hepatitis B, C;
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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033277
Other Study ID Numbers  ICMJE Multi-cited POI Recovery
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hongmei Wang, Chinese Academy of Sciences
Study Sponsor  ICMJE Chinese Academy of Sciences
Collaborators  ICMJE The Third Affiliated Hospital of Guangzhou Medical University
Investigators  ICMJE
Principal Investigator: Hongmei Wang, Doctor State Key Laboratory of Stem Cell and Reproductive Biology
PRS Account Chinese Academy of Sciences
Verification Date January 2017

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