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

NACompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

February 22, 2016

Primary Completion Date

July 22, 2022

Study Completion Date

July 22, 2022

Conditions
InfertilityAsherman Syndrome
Interventions
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.

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.

Trial Locations (1)

210008

Nanjing Drum Tower Hospital, Nanjing

All Listed Sponsors
collaborator

Changzhou Maternal and Child Care Hospital

OTHER

lead

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

NCT02680366 - Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells | Biotech Hunter | Biotech Hunter