Clinical trial NCT02204358: Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
Official title: Clinical Study of the Treatment of Infertility Caused by Severe Intrauterine Adhesions by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Intrauterine Adhesions
Endometrial Dysplasia
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide clinical evidence for the treatment of uterine infertility

Detailed description: Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is no effective treatment to the infertility caused by severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe intrauterine adhesions.Collagen is the main component of the extracellular matrix with good biocompatibility, and it has been approved for the reparation of skin and oral mucosa by State Food and Drug Administration. Bone marrow stem cells have been used in the clinical treatment of blood diseases, and achieved good results. In this study, collagen scaffold and autologous bone marrow stem cells are combined, and they showed good biological safety

Eligibility criteria: Inclusion Criteria:

* Infertility caused by serious intrauterine adhesions or endometrial dysplasia
* Hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia
* Monitoring of endometrial cycle
* Sign a consent form
* Follow the test plan and follow-up process

Exclusion Criteria:

* Abnormal chromosome karyotype
* Congenital uterine malformations
* Severe endometriosis
* Severe adenomyosis
* Contraindications to pregnancy
* Contraindications to bone marrow collection
* Contraindications to hormone replacement therapy
* Medical history of pelvic tumors or receiving pelvic radiotherapy
* Unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period

Primary outcomes:
measure: Reduction of intrauterine scar area,the change of intrauterine adhesion
timeFrame: up to 3 months
Secondary outcomes:
measure: The change of endometrial thickness
timeFrame: up to 1 month
measure: The change of endometrial thickness
timeFrame: up to 2 months
measure: menstrual blood volume The change of menstrual blood volume
timeFrame: baseline and 1 month
Other outcomes:
measure: rate of pregnancy
timeFrame: 2 years
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Yali HU, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: