ChiCTR‐IOR‐16008961.
Study name | An assessor‐blind, open‐label, randomised, parallel‐group, non‐inferiority study to compare the clinical pregnancy rate of interventional ultrasound sclerotherapy to surgical intervention on women with hydrosalpinx before in vitro fertilization and embryo transfer |
Methods | Parallel RCT |
Participants | Inclusion criteria: 1. Patients with unilateral or bilateral hydrosalpinges visible by ultrasound; 2. Aged between 20 to 37 years; 3. Period of infertility > 1 year; 4. Body mass index between 19 and 29; 5. Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations; 6. AFC = 7; 7. AMH level 0.24 to 11.78ng/ml; 8. Midluteal phase gonadotropin‐releasing hormone agonist (GnRH‐a) long down‐regulation protocol; 9. Normal recent semen analysis (according to WHO criteria). Exclusion criteria: 1. Uterine fibroid requiring surgical removal; 2. Endometriosis or adenomyosis; 3. Male factor of infertility requiring ICSI; 4. Previous IVF cycles; 5. History of recurrent miscarriage; 6. Endocrinologic disorders; 7. Presence of systemic disease contraindicating pregnancy. |
Interventions | Control group: surgery group (not specified). Experimental group: ultrasound sclerotherapy. |
Outcomes | 1. Clinical pregnancy rate (not defined) 2. Live birth rate (not defined) 3. Pregnancy loss rate (not defined) 4. Ectopic pregnancy rate (not defined) 5. Ongoing pregnancy in a transfer cycle (not defined). |
Starting date | Recruitment pending |
Contact information | duxin@jarodx.com |
Notes | Written correspondence to the authors remained unanswered up to the date of publication of this review. |