Infertility Clinical Trial
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
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.
Status | Completed |
Enrollment | 152 |
Est. completion date | July 22, 2022 |
Est. primary completion date | July 22, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | 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 ?-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. |
Country | Name | City | State |
---|---|---|---|
China | Nanjing Drum Tower Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Changzhou Maternal and Child Care Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | at 3 and 6 months post-operation | |
Secondary | 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. | at 3 and 6 months post-operation | |
Secondary | Re-adhesion rate at the second-look hysteroscopy | at 3 months post-operation | ||
Secondary | AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation | at 3 months post-operation | ||
Secondary | Miscarriage rate | up to 24 months | ||
Secondary | preterm birth rate | up to 24 months | ||
Secondary | ectopic pregnancy rate | up to 24 months | ||
Secondary | live birth rate | up to 24 months |
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