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Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells

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ClinicalTrials.gov Identifier: NCT02680366
Recruitment Status : Unknown
Verified March 2016 by Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
First Posted : February 11, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary:
This study evaluates the addition of collagen scaffold loaded with autologous bone marrow mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter balloon.

Condition or disease Intervention/treatment Phase
Infertility Asherman Syndrome Device: collagen/ABMNC scaffold Device: Foley catheter balloon Phase 2

Detailed Description:
Severe asherman syndrome will lead to infertility, and the most common method to treat asherman syndrome is operating to dissect adhesions. In order to prevent the postoperative re-adhesion, many physical isolation measures have been tried. However, they don't improve the microenvironment of endometrial regeneration. It's reported that bone marrow mononuclear cells have good effects on the functional recovery of injured uterus. This study will determine whether collagen scaffolds loaded with autologous bone marrow mononuclear cells will be more effective than Foley balloon catheters at treating infertile women with severe intrauterine adhesions who have taken hysteroscopic adhesiolysis. In addition, the study will be carried out in 2 centers, one is the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, the other is Changzhou Maternal and Child Health Care Hospital that is in Jiangsu Province.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Single-blind, Controlled Clinical Trial of Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: collagen/ABMNC scaffold
collagen/ABMNC scaffold covered on Foley catheter balloon inserted after hysteroscopic adhesiolysis
Device: collagen/ABMNC scaffold
The patients will receive a bone marrow puncture to collect bone marrow cells which are used to isolation of ABMNCs. After that, hysteroscopic adhesiolysis will be done according to the patient's uterine adhesion. Then, the collagen/ABMNCs scaffold was covered on a Foley catheter balloon and placed into the uterine cavity. The catheter balloon was kept for 24 hours and then removed. Oral antibiotics were given to prevent infection in the second and third days after operation. 72 hours after the surgery, a vaginal speculum examinations will be done in order to make patients unknown about their arms. Estrogen will be administrated for 3 cycles to support the endometrial regeneration after the surgery. The clinical follow up will be done at 1, 3 and 6 months after the procedure.

Active Comparator: Foley catheter balloon
Foley catheter balloon inserted after hysteroscopic adhesiolysis
Device: Foley catheter balloon
The patients will receive a sham bone marrow puncture which just has a local anesthesia and collects no bone marrow cells to isolation. After that, hysteroscopic adhesiolysis will be done according to the patient's uterine adhesion. And then, a Foley catheter balloon will be placed into the uterine cavity and kept for 72 hours before it is removed. Oral antibiotics were given to prevent infection in the second and third days after operation. Estrogen will be administrated for 3 cycles to support the endometrial regeneration after the surgery. The clinical follow up will be done at 1, 3 and 6 months after the procedure.




Primary Outcome Measures :
  1. Persistent pregnancy rate [ Time Frame: up to 24 months ]
    A successful clinical pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart activity and the size of the fetus is in consistent with the gestational week.


Secondary Outcome Measures :
  1. Menstrual blood volume [ Time Frame: at 3 and 6 months ]
    Understanding the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days, which will be compared with pre-operation.

  2. Endometrial thickness [ Time Frame: at 1, 3 and 6 months ]
    Measure the endometrial thickness during ovulation by ultrasound by the same trained medical sonographers at 1, 3 and 6 months after surgery, comparing with pre-operation.

  3. Endometrial blood supply [ Time Frame: at 1, 3 and 6 months ]
    Measure the endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers at 1, 3 and 6 months after surgery, comparing with pre-operation.

  4. Reduction of intrauterine scar area [ Time Frame: up to 3 month ]
    Evaluating the reduction of scar and its area by hysteroscopy compared with pre-operation.

  5. Miscarriage rate [ Time Frame: up to 24 months ]
  6. placenta adhesion rate [ Time Frame: up to 24 months ]
  7. live- birth rate [ Time Frame: up to 24 months ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Having a clear desire to fertility;
  • Infertility that is defined as a women fails to become pregnant after having a normal sex life for two years without contraception.
  • Hysteroscopy examination confirmed intrauterine adhesions(patients who has at least one of the three symptoms which are amenorrhea, hypomenorrhea or infertility, and hysteroscopy or histologic diagnosis of intrauterine adhesions), meeting American Fertility Society diagnostic criteria Ⅱ-III;
  • Normal ovarian function;
  • Regular Menstrual cycles and menstruation is normal before abortion or curettage;
  • BMI< 30 kg/m2;
  • Sign a consent form;
  • Follow the test plan and follow-up process.

Exclusion Criteria:

  • Hereditary diseases;
  • Simple thin endometrium with no uterine cavity adhesion;
  • Simple Uterine scar formation with no uterine cavity adhesion after hysteroscopic adhesiolysis;
  • Contraindications to bone marrow collection or assisted reproductive technology;
  • History of malignant tumor;
  • Other diseases associated with the uterus: uterine fibroids, severe adenomyosis, severe malformations of the uterus;
  • Abnormal blood coagulation, liver and kidney dysfunction, or other diseases which the researchers think may affect the study(such as: uncontrolled hypertension, diabetes, sexually transmitted diseases);
  • With a positive urine pregnancy test;
  • Participating in other clinical studies at the same time;
  • Hysteroscopic adhesiolysis more than 3 times in the past.

Information from the National Library of Medicine

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): NCT02680366


Contacts
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Contact: Yali Hu, MD,PhD 02583304616 ext 66808 glyyhuyali@163.com

Locations
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China, Jiangsu
Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Yali Hu, MD,PhD    02583304616 ext 66808    glyyhuyali@163.com   
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Principal Investigator: Yali Hu, MD,PhD The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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Responsible Party: Yali Hu, MD,PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT02680366     History of Changes
Other Study ID Numbers: 201600301
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Infertility
Gynatresia
Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female