Clinical trial NCT02680366: Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Asherman Syndrome
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Changzhou Maternal and Child Care Hospital
First posted: 2016-02-11
Enrollment: 152
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: BMSCs group (BMSCs-scaffold plus Foley catheter) or control group (only Foley catheter).
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: up to 24 months
Secondary outcomes:
measure: Menstrual volumes and menstrual improvement:
timeFrame: at 3 and 6 months post-operation
measure: Maximal endometrial thickness
timeFrame: at 3 and 6 months post-operation
measure: Re-adhesion rate at the second-look hysteroscopy
timeFrame: at 3 months post-operation
measure: AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation
timeFrame: at 3 months post-operation
measure: Miscarriage rate
timeFrame: up to 24 months
measure: preterm birth rate
timeFrame: up to 24 months
measure: ectopic pregnancy rate
timeFrame: up to 24 months
measure: live birth rate
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Yali Hu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: