Infertility, Intrauterine Adhesions
Conditions
Brief summary
Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness 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 limited treatment to the infertility caused by severe IUA especially recurrent IUA after adhesiolysis which hinders embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe recurrent intrauterine adhesions. Collagen is the main component of the extracellular matrix with good biocompatibility, UC-MSCs have been used in the clinical treatment of diseases, and achieved good results. In this study, collagen scaffold and umbilical cord blood-derived mesenchymal stem cells are combined, and they showed good biological safety.
Interventions
PROCEDUREUC-MSCs therapy
Before considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits.
Sponsors
Institute of genetic development, Chinese Academy of Sciences
Institute of Zoology, Chinese Academy of Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Secondary infertility or failure of embryo transfer caused by recurrent intrauterine adhesions who desired to be pregnant * Hysteroscopy examination confirmed intrauterine adhesions * Sign a consent form * Follow the test plan and follow-up process
Exclusion criteria
* have hysteroscopic contraindications * Chromosome karyotype abnormalities * Congenital uterine malformations * Severe adenomyosis * Contraindications to estradiol treatment * Medical history of pelvic tumors or receiving pelvic radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate | 30 months | A baby born alive after 20 weeks gestation was classified as a live birth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ongoing pregnant rate | 30 months | The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks |
| Reduction of intrauterine adhesion | 3 months post-surgery | Hysteroscopic inspection to verify degree of adhesion |
| The change of endometrial thickness | up to 3 months | Measure the endometrial thickness during late proliferating phase by ultrasound |
Other
| Measure | Time frame | Description |
|---|---|---|
| The change of menstrual blood volume | baseline and 1 month | Understanding the menstrual blood volume after surgery comparing with pre-operation. |
Countries
China
Outcome results
None listed