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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Infertility, Intrauterine Adhesions

Intervention / Treatment
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* Procedure: UC-MSCs therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UC-MSCs therapy<br>transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions | Procedure: UC-MSCs therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | A baby born alive after 20 weeks gestation was classified as a live birth. | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of intrauterine adhesion | Hysteroscopic inspection to verify degree of adhesion | 3 months post-surgery | 
| The change of endometrial thickness | Measure the endometrial thickness during late proliferating phase by ultrasound | up to 3 months | 
| ongoing pregnant rate | The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks | 30 months |