Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
- Conditions
- InfertilityAsherman Syndrome
- Interventions
- Device: collagen/ABMNC scaffoldDevice: Foley catheter balloon
- Registration Number
- NCT02680366
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 152
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description collagen/ABMNC scaffold collagen/ABMNC scaffold collagen/ABMNC scaffold covered on Foley catheter balloon inserted after hysteroscopic adhesiolysis Foley catheter balloon Foley catheter balloon Foley catheter balloon inserted after hysteroscopic adhesiolysis
- Primary Outcome Measures
Name Time Method Ongoing pregnancy rate 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
Name Time Method preterm birth rate up to 24 months Re-adhesion rate at the second-look hysteroscopy at 3 months post-operation ectopic pregnancy rate up to 24 months live birth rate up to 24 months Miscarriage rate up to 24 months Maximal endometrial thickness at 3 and 6 months post-operation Measure the endometrial thickness during ovulation by ultrasound by the same trained medical sonographers at 3 and 6 months after surgery, comparing with pre-operation.
Menstrual volumes and menstrual improvement: at 3 and 6 months post-operation PBAC scores in the third and sixth menstrual cycles after the initial adhesiolysis and PBAC scores increase compared to pre-operation
AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation at 3 months post-operation
Trial Locations
- Locations (1)
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China