Endometrial Fibrosis, Infertility, Female, of Uterine Origin
Conditions
Keywords
thin endometrium, infertility
Brief summary
Thin endometrium will lead to hypomenorrhea，infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. Patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. This randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.
Interventions
DRUGCBD-bFGF
CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound
DRUGCollagen/BMMNCs
A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound
DRUGEstrogen
Patients will receive regular estrogen therapy
Sponsors
Chinese Academy of Sciences
Yali Hu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
1.Patients with thin endometrium (4mm≤ EMT \<7mm )or scarred endometrium (scarred area≤70%) which is nonresponsive to estrogen stimulation 2.Infertile patients with clear fertility desires 3.20-42 years old 4.Normal ovarian function or with frozen embryos 5.Willing to participate in follow-up
Exclusion criteria
1. Endometrial thickness \<4mm or scarred endometrial area\>70% 2. Uterine cavity out of shape and the cavity depth\<6.5mm 3. Abnormal chromosome karyotype 4. Uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis 5. Systemic diseases: hypertension, diabetes, and so on 6. Contraindications to pregnancy 7. Contraindications to hormone replacement therapy 8. Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other clinical studies 10\. Unable to adhere to the follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 24 months | The presence of a living intrauterine fetus on TVU at the 12th week of gestation |
| Endometrial thickness | 6 months | Endometrial thickness evaluated by transvaginal sonography during late proliferative phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy related complications | 24 months | Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications |
| Menstrual blood volume | 6 months | The change of menstrual blood volume after treatment compared with pre-treatment |
| Histological changes of endometrium | 12 months | Histological changes of the thin endometrium before and after treatment |
| Endometrial blood flow | 6 months | Endometrial blood flow evaluated by transvaginal sonography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 24 months | The occurrence of infections, allergies, abdominal pain, uterine perforation and etc. |
Countries
China
Contacts
Primary ContactYali Hu, MD,PhD
Outcome results
None listed