Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
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|ClinicalTrials.gov Identifier: NCT02204358|
Recruitment Status : Unknown
Verified July 2014 by Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was: Recruiting
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Infertility Intrauterine Adhesions Endometrial Dysplasia||Procedure: autologous bone marrow stem cells||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of the Treatment of Infertility Caused by Severe Intrauterine Adhesions by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||December 2015|
Experimental: autologous bone marrow stem cells
Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.
Procedure: autologous bone marrow stem cells
Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.
If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.
- Reduction of intrauterine scar area,the change of intrauterine adhesion [ Time Frame: up to 3 months ]hysteroscope ,understanding improvement of uterine cavity form,the degree and nature of adhesion or the vanishment of intrauterine adhesion,and the reduction of scar and its area,comparing with pre-operation
- The change of endometrial thickness [ Time Frame: up to 1 month ]Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.
- The change of endometrial thickness [ Time Frame: up to 2 months ]Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.
- menstrual blood volume The change of menstrual blood volume [ Time Frame: baseline and 1 month ]Understanding the menstrual blood volume after surgery ,the number of sanitary napkins per day ,and number of days,comparing with pre-operation.
- rate of pregnancy [ Time Frame: 2 years ]
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): NCT02204358
|Contact: Yali Hu, MD PhD||02583304616 ext firstname.lastname@example.org|
|Nanjing Drum Tower Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210008|
|Contact: Yali HU, MD,PhD 02583304616 ext 66808 email@example.com|
|Principal Investigator:||Yali HU, MD,PhD||Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|