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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list