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

Hydrosalpinx Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03521128
• Other study ID #: 2018-04
• Status: Withdrawn
• Phase: N/A
• Start date: May 5, 2018
• Est. completion date: July 2029

Study information

• Verified date: September 2019
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2029
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrosalpinx
• Infertility
• IVF-ET

Intervention

Procedure:
• radiological 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.
• laparoscopic 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.

Locations

Country	Name	City	State
China	ShangHai JIAI Genetics&IVF Institute	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (6)

Aboulghar MA, Mansour RT, Serour GI. Controversies in the modern management of hydrosalpinx. Hum Reprod Update. 1998 Nov-Dec;4(6):882-90. Review. — View Citation

Arora P, Arora RS, Cahill D. Essure(®) for management of hydrosalpinx prior to in vitro fertilisation-a systematic review and pooled analysis. BJOG. 2014 Apr;121(5):527-36. doi: 10.1111/1471-0528.12533. Epub 2014 Jan 3. Review. — View Citation

Camus E, Poncelet C, Goffinet F, Wainer B, Merlet F, Nisand I, Philippe HJ. Pregnancy rates after in-vitro fertilization in cases of tubal infertility with and without hydrosalpinx: a meta-analysis of published comparative studies. Hum Reprod. 1999 May;14(5):1243-9. — View Citation

Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD002125. doi: 10.1002/14651858.CD002125.pub3. Review. — View Citation

Li Q, Kuang YP, Yang HL, Fu YL, Sun H, Fan LP, Shi HB. [Application of fallopian tube embolization before in vitro fertilization and embryo transfer dealing with the hydrosalpinx]. Zhonghua Fu Chan Ke Za Zhi. 2008 Jun;43(6):414-7. Chinese. — View Citation

Xu B, Zhang Q, Zhao J, Wang Y, Xu D, Li Y. Pregnancy outcome of in vitro fertilization after Essure and laparoscopic management of hydrosalpinx: a systematic review and meta-analysis. Fertil Steril. 2017 Jul;108(1):84-95.e5. doi: 10.1016/j.fertnstert.2017.05.005. Epub 2017 Jun 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	positive hCG level	defined with the result of serum ß-hCG =10 mIU/mL.	A blood hCG test is performed 14 days after the FET, up to 14 days
Secondary	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
Secondary	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
Secondary	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
Secondary	multiple pregnancy	more than one intrauterine sacs on scanning	multiple pregnancy beyond gestation 12 weeks up to 12 weeks
Secondary	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
Secondary	ectopic pregnancy	pregnancy outside the uterine cavity	ectopic pregnancy during first trimester, up to 12 weeks
Secondary	birth weight	birth weight of the baby delivered	a live birth after 22 weeks gestation, through study completion, an average of 1 year