Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Last updated: March 25, 2022
Sponsor: Li-jun Ding
Overall Status: Active - Recruiting

Phase

N/A

Condition

Perimenopause

Treatment

N/A

Clinical Study ID

NCT05308342
SZ-POF-2019-4
  • Ages 20-39
  • Female

Study Summary

This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Those who meet the POF diagnostic criteria and have no spontaneous follicularactivity;
  2. Married, 20 years old ≤ age < 40 years old;
  3. The average diameter of each ovary is > 10 mm;
  4. Have agreed to sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. Female and/or male chromosomal abnormalities;
  2. Endometriosis, adenomyosis;
  3. Postoperative ovarian borderline or malignant tumor;
  4. Uterine dysplasia;
  5. Associated with female autoimmune disease or other serious internal surgical diseases;
  6. hormone replacement contraindications;
  7. In the past 1 year, had received an experimental study of premature ovarian failure inthe external hospital;
  8. Male azoospermia or severe oligozoospermia.

Study Design

Total Participants: 66
Study Start date:
November 20, 2019
Estimated Completion Date:
December 01, 2023

Study Description

According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells (test group). Group B was the hormone replacement group (control group).

Connect with a study center

  • Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

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