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Completed

NCT Number: NCT03592849

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

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.

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Key information

Conditions

Infertility, Female Endometrium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

20 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infertile patients with clear fertility desires
  • Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective
  • 20-42 years old
  • Normal ovarian function or with frozen embryos
  • Willing to actively cooperate with postoperative follow-up

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: collagen scaffold

Primary outcomes

  1. endometrial thickness

    Time frame: 12 months

    endometrium thickness evaluated by transvaginal sonography during late proliferating phase

Secondary outcomes

  1. ongoing pregnancy rate

    Time frame: 24 months

    the presence of a living intrauterine fetus on TVU at the 12th week of gestation

  2. live birth rate

    Time frame: 24 months

    a live born baby ≥28 weeks of gestation

  3. endometrial blood flow

    Time frame: 6 months

    uterine blood flow evaluated by transvaginal sonography

Other outcomes

  1. menstrual blood volume

    Time frame: baseline and 6 month postoperation

    the change of menstrual blood volume after surgery compared with pre-operation

  2. adverse event rate

    Time frame: 30 months

    the occurrence of infections、allergies、abdominal pain postoperation

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 19, 2018
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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