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NCT Number: NCT03724617

Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium

This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.

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Key information

Conditions

Thin Endometrium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Intrauterine Adhesion Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid.
  • HBVAg negative, HCV negative, HIV negative, syphilis negative
  • Normal bone marrow morphology, normal blood routine
  • Previously failed to receive relevant stem cell therapy

Exclusion criteria

  • 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
  • contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.
  • Patients without fertility requirements

Treatment and study plan

umbilical cord mesenchymal stem cells combined with collagen scaffold

Drug

3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded.

Primary outcomes

  1. the change of endometrial thickness

    Time frame: Change from Baseline endometrial thickness at 6 months

    B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.

Secondary outcomes

  1. pregnancy rate

    Time frame: pregnancy rate at 1 year

    pregnancy rate = (pregnancy / observations) × 100%

  2. live birth rate

    Time frame: live birth rate at 1 year

    live birth rate = (live births / observations) × 100%

  3. abortion rate

    Time frame: abortion rate at 1 year

    abortion rate = (number of abortions / observations) × 100%

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

Clinical Study of Stem Cells in the Treatment of Thin Endometrium

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2018
Registry last updated
Apr 13, 2021

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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