search
Back to results

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

Primary Purpose

Infertility, Asherman Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
collagen/ABMNC scaffold
Foley catheter balloon
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Nanjing Drum Tower Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

collagen/ABMNC scaffold

Foley catheter balloon

Arm Description

collagen/ABMNC scaffold covered on Foley catheter balloon inserted after hysteroscopic adhesiolysis

Foley catheter balloon inserted after hysteroscopic adhesiolysis

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate
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

Menstrual volumes and menstrual improvement:
PBAC scores in the third and sixth menstrual cycles after the initial adhesiolysis and PBAC scores increase compared to pre-operation
Maximal endometrial thickness
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.
Re-adhesion rate at the second-look hysteroscopy
AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation
Miscarriage rate
preterm birth rate
ectopic pregnancy rate
live birth rate

Full Information

First Posted
January 30, 2016
Last Updated
November 24, 2022
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Changzhou Maternal and Child Care Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02680366
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
July 22, 2022 (Actual)
Study Completion Date
July 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Changzhou Maternal and Child Care Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Asherman Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
BMSCs group (BMSCs-scaffold plus Foley catheter) or control group (only Foley catheter).
Masking
Participant
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
collagen/ABMNC scaffold
Arm Type
Experimental
Arm Description
collagen/ABMNC scaffold covered on Foley catheter balloon inserted after hysteroscopic adhesiolysis
Arm Title
Foley catheter balloon
Arm Type
Active Comparator
Arm Description
Foley catheter balloon inserted after hysteroscopic adhesiolysis
Intervention Type
Device
Intervention Name(s)
collagen/ABMNC scaffold
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Foley catheter balloon
Intervention Description
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 Measure Information:
Title
Ongoing pregnancy rate
Description
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.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Menstrual volumes and menstrual improvement:
Description
PBAC scores in the third and sixth menstrual cycles after the initial adhesiolysis and PBAC scores increase compared to pre-operation
Time Frame
at 3 and 6 months post-operation
Title
Maximal endometrial thickness
Description
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.
Time Frame
at 3 and 6 months post-operation
Title
Re-adhesion rate at the second-look hysteroscopy
Time Frame
at 3 months post-operation
Title
AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation
Time Frame
at 3 months post-operation
Title
Miscarriage rate
Time Frame
up to 24 months
Title
preterm birth rate
Time Frame
up to 24 months
Title
ectopic pregnancy rate
Time Frame
up to 24 months
Title
live birth rate
Time Frame
up to 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yali Hu, MD,PhD
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Both the study protocol and the statistical analysis plan are available on request.
IPD Sharing Time Frame
The data are available on reasonable request beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal will be given access to the data to achieve aims in the proposal.

Learn more about this trial

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

We'll reach out to this number within 24 hrs