Clinical Study on the Effect of Umbilical Cord Mesenchymal Stem Cell Exosomes on Endometrial Repair of Intrauterine Adhesions

NCT07416578 | Active Not Recruiting DMC

• 1 other identifier: 2023ZSLYFEC-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Intrauterine adhesions (IUA) is a group of diseases caused by endometrial injury leading to occlusion of the uterine cavity and serious abnormality of the uterine cavity morphology, which causes primary or secondary infertility by affecting embryo implantation. At present, the poor effectiveness of clinical treatment methods has made the thin endometrium after intrauterine adhesions an urgent problem to be solved in the clinical field of assisted reproduction. Stem cells with multi-directional differentiation potential provide a new idea for the treatment of cervical adhesions. However, due to limitations such as stem cell extraction, technical conditions, and ethical issues, clinical application cannot be widely carried out. Exosomes are vesicle structures produced by paracrine secretion of cells, containing abundant proteins, RNA, etc., and mediating information exchange between cells. Recent studies have found that stem cells play a role in tissue repair mainly through paracrine, and stem cell-derived exosomes have similar functions to stem cells. Human cord mesenchymal stem cells were selected as an intervention for this clinical study because of their wide source, easy access, and low immunogenicity. Therefore, in this clinical study, the investigator will evaluate the clinical safety and efficacy of infusing human umbilical cord mesenchymal stem cell exosomes into the uterine cavity for the treatment of thin endometrium after intrauterine adhesions.

Conditions

Intrauterine Adhesions; Exosomes

Outcome Measures

Primary Outcomes (1)

• Endometrial thickness

  The thickness of the endometrium was measured through three-dimensional color ultrasound examination of the uterus. The thickness (in millimeters) of the endometrium before and after the hysteroscopy procedure was recorded.

  One month after hysteroscopy surgery

Secondary Outcomes (2)

• Clinical pregnancy rate

  1-1.5year

• Live birth rate

  1-1.5year

Study Arms (2)

The conventional treatment group

OTHER

traditional hormone replacement therapy

Drug: HRT

Exosomes group

EXPERIMENTAL

Exosomes group：After hysteroscopic surgery, exosomes were infused into the uterus immediately, and traditional hormone replacement therapy (HRT) was given after surgery.

Combination Product: Exosmoes; Drug: HRT

Interventions

Exosmoes COMBINATION_PRODUCT

After hysteroscopy, immediate intracavitary perfusion therapy with exosomes was administered.

Exosomes group

HRT DRUG

After hysteroscopy, traditional hormone replacement therapy (HRT) cycle drug treatment was performed (from the day of the surgery to the 25th day of the menstrual cycle, 3 mg of estradiol valerate (Climen) was taken twice a day, and on the 16th day of the menstrual cycle, 10 mg of dydrogesterone (Duphaston) was added twice a day for 10 days).

Exosomes group; The conventional treatment group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (1) The subjects were able to fully understand the purpose of the screening and the trial, had sufficient understanding and compliance with the research protocol, and signed the informed consent form; (2) The subjects were aged between 20 and 38 years old; (3) The body mass index was 18-27 kg/m2; (4) The menstrual cycle was regular for at least half a year, with a duration of 27-35 days; (5) The ovarian reserve was normal, with at least 6 follicles (AFC), and the serum follicle-stimulating hormone (FSH) level on the 2nd-4th day of the menstrual cycle was between 1-10 IU/L, and other basic hormone indicators were within the normal range of clinical laboratories; (6) The serum human immunodeficiency virus (HIV) antibody, Treponema pallidum particle agglutination test (TPPA), hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (HCV-Ag) tests were negative within half a year; (7) Previous hysteroscopy diagnosis was moderate to severe intrauterine adhesions (AFS \> 5 points); (8) There was a history of canceling frozen embryo transfer due to repeated B-ultrasound monitoring of thin endometrium and poor endometrial response (HRT cycle or/and late proliferative endometrium thickness \< 6mm).

You may not qualify if:

• (1) Those who cannot accept the treatment and observation process as required by the trial; (2) Those with contraindications for hysteroscopic surgery; (3) Congenital uterine malformations; (4) Severe adenomyosis; (5) Uterine fibroids that may affect embryo implantation; (6) Other uterine factors judged by the researchers to be unsuitable for embryo implantation; (7) Patients with chromosomal abnormalities; (8) Patients with reproductive system tuberculosis, or those with immune system diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.); (9) Chronic wasting or bleeding disorders; (10) Unaddressed tubal hydrosalpinx; (11) Contraindications for estrogen therapy; (12) Patients with systemic diseases， such as thrombosis， heart and lung diseases， hematological system diseases and malignant tumors， etc.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

No. 26, Second Horizontal Road, Yan Village, Tianhe District

Guangzhou, Guangdong, 510600, China

Location

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The conventional treatment group and Exosomes group

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 18, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)