Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells
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ClinicalTrials.gov Identifier: NCT02313415 |
Recruitment Status :
Completed
First Posted : December 10, 2014
Last Update Posted : October 24, 2017
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Condition or disease | Intervention/treatment | Phase |
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Infertility Intrauterine Adhesions | Procedure: UC-MSCs therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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) |
Actual Study Start Date : | November 28, 2014 |
Actual Primary Completion Date : | January 28, 2015 |
Actual Study Completion Date : | August 31, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: UC-MSCs therapy
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions
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Procedure: UC-MSCs therapy
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. |
- live birth rate [ Time Frame: 30 months ]A baby born alive after 20 weeks gestation was classified as a live birth.
- Reduction of intrauterine adhesion [ Time Frame: 3 months post-surgery ]Hysteroscopic inspection to verify degree of adhesion
- The change of endometrial thickness [ Time Frame: up to 3 months ]Measure the endometrial thickness during late proliferating phase by ultrasound
- ongoing pregnant rate [ Time Frame: 30 months ]The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks
- The change of menstrual blood volume [ Time Frame: baseline and 1 month ]Understanding the menstrual blood volume after surgery comparing with pre-operation.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313415
China, Jiangsu | |
Nanjing Drum Tower Hospital | |
Nanjing, Jiangsu, China, 210008 |
Principal Investigator: | Yali HU, MD,PhD | Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
Responsible Party: | Yali Hu, MD,PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
ClinicalTrials.gov Identifier: | NCT02313415 |
Other Study ID Numbers: |
20141206 |
First Posted: | December 10, 2014 Key Record Dates |
Last Update Posted: | October 24, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Infertility Tissue Adhesions Cicatrix Fibrosis Pathologic Processes |