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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility, Female, Endometrium

Intervention / Treatment
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* Procedure: UC-MSCs therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 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
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 thin endometrium or endometrial scarring | Procedure: UC-MSCs therapy<br>* 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.<br>* Other names: collagen scaffold;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness | endometrium thickness evaluated by transvaginal sonography during late proliferating phase | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate | the presence of a living intrauterine fetus on TVU at the 12th week of gestation | 24 months | 
| live birth rate | a live born baby ≥28 weeks of gestation | 24 months | 
| endometrial blood flow | uterine blood flow evaluated by transvaginal sonography | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thin endometrium, infertility