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

Not Applicable

• Conditions: Premature Ovarian Insufficiency
• Interventions: Procedure: transplantation of human UC-MSCs into ovaries of POI patients; Drug: hormone replacement treatment

• Registration Number: NCT05308342
• Lead Sponsor: Li-jun Ding

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2019-11-20
• Study First Submitted: 2019-11-25
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-25
• Last Update Submitted: 2022-03-25
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

1. Those who meet the POF diagnostic criteria and have no spontaneous follicular activity;
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 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 in the external hospital;
8. Male azoospermia or severe oligozoospermia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC-MSCs+hormone replacement group	transplantation of human UC-MSCs into ovaries of POI patients	Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group).
UC-MSCs+hormone replacement group	hormone replacement treatment	Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group).
hormone replacement group	hormone replacement treatment	Group B was the hormone replacement group (control group).

Primary Outcome Measures

Name	Time	Method
Follicular development rate	9-12 months	Follicular development and hormonal examination were performed 1 week before treatment and at 1, 2, and 3 weeks after treatment to evaluate the development of follicles. If there is no follicular development in the third week, stop the drug after 1 week, and contact the next treatment time after menstruation. During the follow-up period to half a year after the end of the last treatment, the follicular development activity rate was observed.

Secondary Outcome Measures

Name	Time	Method
Changes in blood flow index in the ovary	9-12 months	Ovarian artery blood flow spectrum PI; RI; S/D (L; R)
Clinical pregnancy rate	9-12 months	Clinical pregnancy was defined as diagnosed by increasing serum concentration of beta-HCG 14 days after embryo transfer, and the subsequent demonstration of an intrauterine gestational sac by ultrasonography on 30 days after embryo transfer

Trial Locations

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China