Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment

Conditions
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IVF-ET, Hydrosalpinx

Intervention / Treatment
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* Procedure: radiological tubal blockage
* Procedure: laparoscopic salpingectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the radiological tubal blockage group<br> | Procedure: radiological tubal blockage<br>* 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.<br>|
| Active Comparator: the laparoscopic salpingectomy group<br> | Procedure: laparoscopic salpingectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | the rate of live births per cycle | a live birth after 22 weeks gestation, through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive hCG level | defined with the result of serum β-hCG ≥10 mIU/mL. | A blood hCG test is performed 14 days after the FET, up to 14 days | 
| clinical pregnancy rate | presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy | presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks | 
| ongoing pregnancy rate | presence of a fetal pole with pulsation at 12 weeks of gestation | iable pregnancy beyond gestation 12 weeks, up to 12 weeks | 
| implantation rate | number of gestational sacs per embryo transferred | number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks | 
| multiple pregnancy | more than one intrauterine sacs on scanning | multiple pregnancy beyond gestation 12 weeks up to 12 weeks | 
| miscarriage rate | defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy. | a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks | 
| ectopic pregnancy | pregnancy outside the uterine cavity | ectopic pregnancy during first trimester, up to 12 weeks | 
| birth weight | birth weight of the baby delivered | a live birth after 22 weeks gestation, through study completion, an average of 1 year |