IVF-ET, Hydrosalpinx
Conditions
Brief summary
Hydrosalpinx (HX) has a detrimental effect on the rates of implantation, pregnancy, live delivery, and early pregnancy loss during in vitro fertilization (IVF). The effectiveness of radiological tubal blockage has not been compared with the standard treatment of laparoscopic salpingectomy in randomized trials. The investigators aim in this randomized trial to compare the live birth rate of radiological tubal blockage versus laparoscopic salpingectomy in infertility women with HX prior to frozen-thawed embryo transfer (FET). Eligible women will be recruited and randomized into one of the following two groups: (1) the radiological tubal blockage group and (2) the laparoscopic salpingectomy group. The primary outcome is the live birth rate.
Interventions
PROCEDUREradiological tubal blockage
In radiological tubal blockage group, under the fluoroscopy of X-ray, after confirming HX by HSG, selective catheterization will be done for the affected tube and micro spring coils will be put in to the interstitial tube and isthmus through micro catheter. The micro spring coil will be placed into the proximal end of the Fallopian tube (unilateral or bilateral depending on whether one or two HX were present) through micro catheter under the fluoroscopy of X-ray. Then HSG will be carried out to check the position of the micro spring coil and confirm complete blockage. Four weeks after the radiological procedure, a HSG will be performed to recheck the position of the micro spring coil and complete blockage of the tubes. FET is proceeded in the next menstrual cycle after HSG examination.
PROCEDURElaparoscopic salpingectomy
In the laparoscopic salpingectomy group, after confirming HX, a unilateral or bilateral salpingectomy will be performed in a standard manner, depending on whether unilateral or bilateral HX are present. In women with extensive pelvic adhesions during laparoscopy, proximal tubal ligation will be performed as an alternative procedure to salpingectomy. FET is proceeded in the next menstrual cycle after the laparoscopic operation.
Sponsors
ShangHai Ji Ai Genetics & IVF Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 43 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 20-43 years at the time of IVF/ICSI treatment * Unilateral or bilateral HX visible on pelvic ultrasound or hysterosalpingogram * At least one frozen embryo or blastocyst available for transfer
Exclusion criteria
* A history of pelvic inflammatory disease within 6 months * HX that were already blocked proximally on hysterosalpingogram * Frozen pelvis from previous laparoscopy * Women with fibroids interfering with radiological tubal blockage * Undergoing preimplantation genetic testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate | a live birth after 22 weeks gestation, through study completion, an average of 1 year | the rate of live births per cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate | presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks | presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy |
| ongoing pregnancy rate | iable pregnancy beyond gestation 12 weeks, up to 12 weeks | presence of a fetal pole with pulsation at 12 weeks of gestation |
| implantation rate | number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks | number of gestational sacs per embryo transferred |
| positive hCG level | A blood hCG test is performed 14 days after the FET, up to 14 days | defined with the result of serum β-hCG ≥10 mIU/mL. |
| miscarriage rate | a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks | defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy. |
| ectopic pregnancy | ectopic pregnancy during first trimester, up to 12 weeks | pregnancy outside the uterine cavity |
| birth weight | a live birth after 22 weeks gestation, through study completion, an average of 1 year | birth weight of the baby delivered |
| multiple pregnancy | multiple pregnancy beyond gestation 12 weeks up to 12 weeks | more than one intrauterine sacs on scanning |
Countries
China
Outcome results
None listed