Completed

Clinical Study of Stem Cells in the Treatment of Thin Endometrium

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What is being tested

umbilical cord mesenchymal stem cells combined with collagen scaffold

Drug
Who is being recruted

Urogenital Diseases+3

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 20 to 40 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2018
See protocol details

Summary

Principal SponsorSir Run Run Shaw Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 29, 2018

Actual date on which the first participant was enrolled.

According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.

Official TitleClinical Study of Stem Cells in the Treatment of Thin Endometrium
NCT03724617
Principal SponsorSir Run Run Shaw Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGynatresiaFemale Urogenital Diseases

Criteria

8 inclusion criteria required to participate
According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.

Women aged 20-40 years with fertility requirements

Infertility patients who are treated in this hospital

After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound.

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6 exclusion criteria prevent from participating
Those who cannot accept the treatment observation process required by the test

There are contraindications for hysteroscopic surgery;

congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation

Patients with chromosomal abnormalities

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sir Run Run Shaw hopital,School of medicine,Zhejiang University

Hangzhou, ChinaOpen Sir Run Run Shaw hopital,School of medicine,Zhejiang University in Google Maps
CompletedOne Study Center
Clinical Study of Stem Cells in the Treatment of Thin Endometrium | PatLynk