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

Li-jun Ding

Status: Unknown

Conditions: Premature Ovarian Insufficiency

Treatments: Drug: hormone replacement treatment; Procedure: transplantation of human UC-MSCs into ovaries of POI patients

Study type: Interventional

Funder types: Other

Identifiers

NCT05308342

SZ-POF-2019-4

Details and patient eligibility

About

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.

Full 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).

Enrollment: 66 estimated patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

66 participants in 2 patient groups

UC-MSCs+hormone replacement group

Experimental group

Description:

Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group).

Treatment:

Procedure: transplantation of human UC-MSCs into ovaries of POI patients

Drug: hormone replacement treatment

hormone replacement group

Active Comparator group

Description:

Group B was the hormone replacement group (control group).

Treatment:

Drug: hormone replacement treatment