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NCT Number: NCT02313415

Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells

Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness for the treatment of uterine infertility.

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Key information

Conditions

Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Intrauterine Adhesions Urogenital Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

About this study

Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is limited treatment to the infertility caused by severe IUA especially recurrent IUA after adhesiolysis which hinders embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe recurrent intrauterine adhesions. Collagen is the main component of the extracellular matrix with good biocompatibility, UC-MSCs have been used in the clinical treatment of diseases, and achieved good results. In this study, collagen scaffold and umbilical cord blood-derived mesenchymal stem cells are combined, and they showed good biological safety.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Secondary infertility or failure of embryo transfer caused by recurrent intrauterine adhesions who desired to be pregnant
  • Hysteroscopy examination confirmed intrauterine adhesions
  • Sign a consent form
  • Follow the test plan and follow-up process

Exclusion criteria

  • have hysteroscopic contraindications
  • Chromosome karyotype abnormalities
  • Congenital uterine malformations
  • Severe adenomyosis
  • Contraindications to estradiol treatment
  • Medical history of pelvic tumors or receiving pelvic radiotherapy

Treatment and study plan

UC-MSCs therapy

Procedure

Before considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits.

Primary outcomes

  1. live birth rate

    Time frame: 30 months

    A baby born alive after 20 weeks gestation was classified as a live birth.

Secondary outcomes

  1. Reduction of intrauterine adhesion

    Time frame: 3 months post-surgery

    Hysteroscopic inspection to verify degree of adhesion

  2. The change of endometrial thickness

    Time frame: up to 3 months

    Measure the endometrial thickness during late proliferating phase by ultrasound

  3. ongoing pregnant rate

    Time frame: 30 months

    The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks

Other outcomes

  1. The change of menstrual blood volume

    Time frame: baseline and 1 month

    Understanding the menstrual blood volume after surgery comparing with pre-operation.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Collaborators

  • Institute of Zoology, Chinese Academy of Sciences
  • Institute of genetic development, Chinese Academy of Sciences

Registry information

Official study title

Clinical Study of the Treatment of Infertility Caused by Recurrent Intrauterine Adhesions by Collagen Scaffold Loaded With Umbilical Cord -Derived Mesenchymal Stem Cells (UC-MSCs)

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Dec 10, 2014
Registry last updated
Oct 24, 2017

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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