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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Chinese Academy of Sciences

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Chinese Academy of Sciences

Dates:
Date Received: January 10, 2017
Date Started: February 2016
Date Completion: July 2018
Last Updated: January 24, 2017
Last Verified: January 2017