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

ISRCTN ISRCTN40458453
DOI https://doi.org/10.1186/ISRCTN40458453
Secondary identifying numbers N/A
Submission date
25/11/2016
Registration date
10/12/2016
Last edited
07/12/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Songying Zhang
Scientific

3# Qing Chun East Road
Hangzhou
310016
China

Study information

Study designSingle-centre prospective randomized controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe 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
Study objectivesMany 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(s)Medical ethics committee, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 16/03/2015
Health condition(s) or problem(s) studiedHydrosalpinx
InterventionParticipants 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 typeProcedure/Surgery
Primary outcome measure1. 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 measures1. 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 study start date12/01/2016
Completion date31/12/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit41 Years
SexFemale
Target number of participants100
Key inclusion criteria1. Women with tubal infertility planning to undergo IVF
2. 18-41 years old
Key exclusion criteria1. Endometriosis
2. Prior ovarian surgery
3. Diminished ovarian reserves
4. Polycystic ovarian syndrome (PCOS)
Date of first enrolment01/01/2017
Date of final enrolment31/12/2018

Locations

Countries of recruitment

  • China

Study participating centre

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

Sponsor information

Health Bureau of Zhejiang Province
Government

216# Qingchun Road
Hangzhou
310006
China

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo be confirmed at a later date
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Mrs Songying Zhang