NCT02680366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

February 22, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

6.4 years

First QC Date

January 30, 2016

Last Update Submit

November 24, 2022

Conditions

InfertilityAsherman Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 24 months

Secondary Outcomes (8)

  • Menstrual volumes and menstrual improvement:

    at 3 and 6 months post-operation

  • Maximal endometrial thickness

    at 3 and 6 months post-operation

  • Re-adhesion rate at the second-look hysteroscopy

    at 3 months post-operation

  • AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation

    at 3 months post-operation

  • Miscarriage rate

    up to 24 months

  • +3 more secondary outcomes

Study Arms (2)

collagen/ABMNC scaffold

EXPERIMENTAL

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

Device: collagen/ABMNC scaffold

Foley catheter balloon

ACTIVE COMPARATOR

Foley catheter balloon inserted after hysteroscopic adhesiolysis

Device: Foley catheter balloon

Interventions

collagen/ABMNC scaffoldDEVICE

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.

collagen/ABMNC scaffold
Foley catheter balloonDEVICE

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.

Foley catheter balloon

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

InfertilityGynatresia

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Yali Hu, MD,PhD

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: BMSCs group (BMSCs-scaffold plus Foley catheter) or control group (only Foley catheter).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

January 30, 2016

First Posted

February 11, 2016

Study Start

February 22, 2016

Primary Completion

July 22, 2022

Study Completion

July 22, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Both the study protocol and the statistical analysis plan are available on request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data are available on reasonable request beginning 3 months and ending 5 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal will be given access to the data to achieve aims in the proposal.

Locations

CN(1)