Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mon… (NCT02680366) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
China152 participantsStarted 2016-02-22
Plain-language 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.
Who can participate
Age range20 Years – 40 Years
SexFEMALE
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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 â…ˇ-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.
What they're measuring
1
Ongoing pregnancy rate
Timeframe: up to 24 months
Trial details
NCT IDNCT02680366
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School