Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells

NCT02204358 | Unknown Phase 4 DMC

• 1 other identifier: 2012022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility; Intrauterine Adhesions; Endometrial Dysplasia

Outcome Measures

Primary Outcomes (1)

• Reduction of intrauterine scar area,the change of intrauterine adhesion

  hysteroscope ,understanding improvement of uterine cavity form,the degree and nature of adhesion or the vanishment of intrauterine adhesion,and the reduction of scar and its area,comparing with pre-operation

  up to 3 months

Secondary Outcomes (3)

• The change of endometrial thickness

  up to 1 month

• The change of endometrial thickness

  up to 2 months

• menstrual blood volume The change of menstrual blood volume

  baseline and 1 month

Other Outcomes (1)

• rate of pregnancy

  2 years

Study Arms (1)

autologous bone marrow stem cells

EXPERIMENTAL

Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.

Procedure: autologous bone marrow stem cells

Interventions

autologous bone marrow stem cells PROCEDURE

Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on. If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.

Also known as: infertility, severe intrauterine adhesions, endometrial dysplasia, collagen scaffold

autologous bone marrow stem cells

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Infertility; Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Yali HU, MD,PhD

  Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yali Hu, MD PhD

CONTACT

02583304616; 819241652@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: July 26, 2014
• First Posted: July 30, 2014
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2015
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

CN (1)