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
|Condition or disease||Intervention/treatment||Phase|
|Infertility Intrauterine Adhesions||Procedure: UC-MSCs therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|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)|
|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|
Experimental: UC-MSCs therapy
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions
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.
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
|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|