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

Not Applicable

Withdrawn

• Conditions: IVF-ET; Hydrosalpinx
• Interventions: Procedure: laparoscopic salpingectomy; Procedure: radiological tubal blockage

• Registration Number: NCT03521128
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-12
• Study Start: 2018-05-05
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-24
• Primary Completion: 2020-05
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the laparoscopic salpingectomy group	laparoscopic salpingectomy	-
the radiological tubal blockage group	radiological tubal blockage	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
multiple pregnancy	multiple pregnancy beyond gestation 12 weeks up to 12 weeks	more than one intrauterine sacs on scanning
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
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.
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
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.

Trial Locations

Locations (1)

ShangHai JIAI Genetics&IVF Institute; 🇨🇳 Shanghai, China