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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Premature Ovarian Insufficiency

Intervention / Treatment
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* Procedure: transplantation of human UC-MSCs into ovaries of POI patients
* Drug: hormone replacement treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who meet the POF diagnostic criteria and have no spontaneous follicular activity; Married, 20 years old ≤ age < 40 years old; The average diameter of each ovary is > 10 mm; Have agreed to sign the informed consent form. Exclusion Criteria: Female and/or male chromosomal abnormalities; Endometriosis, adenomyosis; Postoperative ovarian borderline or malignant tumor; Uterine dysplasia; Associated with female autoimmune disease or other serious internal surgical diseases; hormone replacement contraindications; In the past 1 year, had received an experimental study of premature ovarian failure in the external hospital; Male azoospermia or severe oligozoospermia.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UC-MSCs+hormone replacement group<br>Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group). | Procedure: transplantation of human UC-MSCs into ovaries of POI patients<br>* UC-MSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the China Food and Drug Administration) are injected into the ovary of patients under transvaginal ultrasonographic (TVUS)-guidance. A total number of 10×106 cells, 5×106 for unilateral ovarian injection) is immediately preserved and transferred for direct injection. After vaginal sterilization, TVUS-guided transplantation is performed by two senior-level medical physicians, using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcare Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The UC-MSC solution is injected into the ovary by using 21-G PTC needles (Hakko Medical Co, Japan) under TVUS guidance.<br>Drug: hormone replacement treatment<br>* Routine estrogen progesterone replacement periodic therapy<br>* Other names: HRT;|
| Active Comparator: hormone replacement group<br>Group B was the hormone replacement group (control group). | Drug: hormone replacement treatment<br>* Routine estrogen progesterone replacement periodic therapy<br>* Other names: HRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicular development rate | 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. | 9-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood flow index in the ovary | Ovarian artery blood flow spectrum PI; RI; S/D (L; R) | 9-12 months | 
| Clinical pregnancy rate | 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 | 9-12 months |