Intrauterine Adhesion
Conditions
Keywords
G-CSF, adhesion reformation, Asherman syndrome
Brief summary
The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.
Detailed description
After hysteroscopic adhesiolysis, patients with moderate to severe intrauterine adhesions will be allocated into 2 groups randomly, with COOK ballon and estrogen and progesterone sequential therapy given to prevent adhesion routinely. 7 day later, G-CSF or normal saline will be injected into the uterine cavity by Tom catheter after removing the balloon respectively. A second hysteroscopic examination will be performed in 2 months to check up the adhesion reformation. In addition, the endometrial thickness after surgery and fertility outcome will be followed up.
Interventions
DRUGG-CSF
7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.
DRUGNormal saline
7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.
DRUGhormone therapy
In all cases hormone therapy was commenced shortly after the operation, consisting of oestradiol valerate at a dose of 6 mg per day for 21-28 days with the addition of medroxyprogesterone acetate at a dose of 6 mg per day for the last 7-10 days of the oestrogen therapy. Following the withdrawal bleed, the hormone therapy was repeated for another cycle.
OTHERCook balloon
At the end of the procedure, the Cook balloon were placed in the uterine cavity of each patient.the device was removed after 7 days.
Sponsors
Wenzhou people's hospital，zhejiang province,China
Ningbo Women & Children's Hospital
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Moderate and severe intrauterine adhesion patients(AFS score ≥5) * age 18-40 * first time receiving hysteroscopic adhesiolysis * provided COOK balloon as adjuvant adhesion prevention treatment * accepting randomized trial
Exclusion criteria
* Mild adhesion patients * uterine shape can't be restored in the end of surgery * abnormal chromosome phenotype * systemic disease * no fertility desire * contradiction of G-CSF injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesion reformation rate | 2 months after first surgery | Adhesion reformation rate after first adhesiolysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | 3 years after first surgery | pregnancy rate after adhesiolysis |
| Live birth rate | 4 years after first surgery | live birth rate after adhesiolysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Endometrial thickness | 1 months after G-CSF injection | Endometrial thickness in the ovulation phase after G-CSF injection |
Countries
China
Contacts
Primary ContactXiaona Lin, Doctor
Outcome results
None listed