The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring

NCT03592849 | Completed

• 1 other identifier: SC201700101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.

Conditions

Infertility, Female; Endometrium

Keywords

thin endometrium; infertility

Outcome Measures

Primary Outcomes (1)

• endometrial thickness

  endometrium thickness evaluated by transvaginal sonography during late proliferating phase

  12 months

Secondary Outcomes (3)

• ongoing pregnancy rate

  24 months

• live birth rate

  24 months

• endometrial blood flow

  6 months

Other Outcomes (2)

• menstrual blood volume

  baseline and 6 month postoperation

• adverse event rate

  30 months

Study Arms (1)

UC-MSCs therapy

EXPERIMENTAL

transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring

Procedure: UC-MSCs therapy

Interventions

UC-MSCs therapy PROCEDURE

After history taking, physical examination, ultrasound examination and hysteroscopy examination，infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.

Also known as: collagen scaffold

UC-MSCs therapy

Eligibility Criteria

• Age: 20 Years - 42 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile patients with clear fertility desires
• Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective
• years old
• Normal ovarian function or with frozen embryos
• Willing to actively cooperate with postoperative follow-up

You may not qualify if:

• With abnormal chromosome karyotype
• With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
• Systemic diseases: hypertension, diabetes, and so on
• Contraindications to pregnancy
• Contraindications to hormone replacement therapy
• Medical history of pelvic tumors or receiving pelvic radiotherapy
• Involved in other clinical studies
• Unable to adhere to the follow-up

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

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

Study Officials

• Yali Hu, MD,PhD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor，Chief Physician of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: September 10, 2018
• Primary Completion: January 31, 2021
• Study Completion: August 31, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)