Condition category
Urological and Genital Diseases
Date applied
25/11/2016
Date assigned
10/12/2016
Last edited
07/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Women with a blocked, fluid-filled Fallopian tube (hydrosalpinx) have lower pregnancy rates (tubal infertility) and increased miscarriage rates after in vitro fertilization (IVF) treatment. Laparoscopic salpingectomy (surgical removal of the fluid-filled tube) is the current standard treatment. Laparoscopic proximal tubal occlusion (surgery to block off the fluid-filled tube) is an alternative treatment to laparoscopic salpingectomy. The aim of this study is to compare pregnancy outcomes after the two treatments.

Who can participate?
Women aged 18-41 with tubal infertility planning to undergo IVF

What does the study involve?
Participants are randomly allocated to undergo either laparoscopic salpingectomy or laparoscopic proximal tubal occlusion before undergoing IVF. Embryo transfers are performed two months after surgery. Participants are routinely called for a blood sample 14 days after the hCG trigger (to trigger the ovaries to release eggs) to measure human chorionic gonadotropin (hCG) hormone levels, and to confirm whether pregnancy has occurred. An ultrasound examination is arranged 5 weeks after embryo transfer for participants with a positive hCG test to confirm the pregnancy. Patients are followed up until pregnancy is completed.

What are the possible benefits and risks of participating?
The treatments may improve pregnancy rate and reduce the ectopic pregnancy and miscarriage rate. However, the treatments are invasive and involve risks related to anaesthesia and surgery.

Where is the study run from?
Sir Run Run Shaw Hospital (China)

When is the study starting and how long is it expected to run for?
January 2016 to December 2019

Who is funding the study?
Zhejiang Province Health High-Level Innovative Talents Training (China)

Who is the main contact?
Mrs Songying Zhang

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Songying Zhang

ORCID ID

Contact details

3# Qing Chun East Road
Hangzhou
310016
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The comparison of pregnancy outcomes in hydrosalpinx patients treated with salpingectomy and proximal tubal occlusion prior to in vitro fertilization embryo transfer: a randomized controlled study

Acronym

Study hypothesis

Many retrospective studies reported significantly lower implantation and pregnancy rates in patients with hydrosalpinges when compared with other types of tubal disease, as well as increasing rates of spontaneous abortions and ectopic pregnancies. The hypothesis is that the pregnancy outcomes of hydrosalpinx patient prior to in vitro fertilization embryo transfer will be better in the salpingectomy group than the proximal tubal occlusion group.

Ethics approval

Medical ethics committee, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 16/03/2015

Study design

Single-centre prospective randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hydrosalpinx

Intervention

Participants are randomised to undergo either modified laparoscopic salpingectomy or modified proximal tubal occlusion prior to in vitro fertilization embryo transfer. Prophylactic antibiotics are transfused to all patients.

Group 1: Undergo the modified laparoscopic “core-pulling” salpingectomy. All salpingectomies are performed laparoscopically.
Group 2: Undergo the modified laparoscopic proximal tubal occlusion. Proximal tubal occlusion is also performed laparoscopically.

Embryo transfers are performed two months after surgery. Patients are routinely called for a blood sample 14 days after hCG trigger to measure human chorionic gonadotropin (hCG), and to confirm whether pregnancy has occurred. An ultrasound examination is arranged 5 weeks after ET for subjects with a positive hCG test to verify the exact location and viability of the pregnancy. Patients are followed up until pregnancy is completed.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Clinical pregnancy, defined as gestation sac and/or fetal pole measured using ultrasound scan at 22 days after embryo transfer
2. Ongoing pregnancy, defined as a fetal heartbeat measured on ultrasound beyond 10-weeks gestation

Secondary outcome measures

1. Implantation rate, defined as the number of gestational sacs on ultrasound divided by the number of embryos transferred, measured using ultrasound scan at 22 days after embryo transfer
2. Ectopic pregnancy at any extrauterine site (considered as an implanted embryo), measured using ultrasound scan at 22 days and 35 days after embryo transfer
3. Miscarriage, measured during the first trimester
4. Live birth rate, measured at birth
5. Ovarian reserve, measured using FSH levels on cycle day 2-3 before and 3 months after the laparoscopic surgery

Overall trial start date

12/01/2016

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with tubal infertility planning to undergo IVF
2. 18-41 years old

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Endometriosis
2. Prior ovarian surgery
3. Diminished ovarian reserves
4. Polycystic ovarian syndrome (PCOS)

Recruitment start date

01/01/2017

Recruitment end date

31/12/2018

Locations

Countries of recruitment

China

Trial participating centre

Sir Run Run Shaw Hospital
3# Qing Chun East Road
Hangzhou
310016
China

Sponsor information

Organisation

Health Bureau of Zhejiang Province

Sponsor details

216# Qingchun Road
Hangzhou
310006
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Zhejiang Province Health High-Level Innovative Talents Training (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from Mrs Songying Zhang

Intention to publish date

31/12/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes