IVF Outcomes After Varicocele Repair

March 23, 2017 updated by: Shaare Zedek Medical Center

The Effect of Preliminary Varicocele Repair on IVF Outcomes in Male Factor Infertility

Infertility has been estimated to affect from 6-18% of couples trying to conceive. In 20-30% of cases, the problem is with the male. Varicocele is a common cause of male factor infertility (MFI) being responsible for 30-35 % of primary and 69-81 % of secondary MFI. Varicocele repair has been shown to improve sperm parameters and increase natural pregnancy rates and the results of assisted reproductive techniques (ART).

There are two possible treatment pathways for varicocele associated male factor infertility. 1) standard IVF/ICSI 2) varicocele repair followed by IVF/ICSI if there is no spontaneous pregnancy. There is however no consensus as to which pathway is preferable and no randomized comparative studies have been carried out.

IVF/ICSI is a standard treatment for infertility but frequently requires repeated treatments to achieve a live birth. The purpose of this study is to determine if the improved sperm parameters caused by prior treatment of the varicocele will result in improvements both in overall pregnancy/birth rates and in IVF/ICSI results.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A varicocele is an abnormal dilation of the pampiniform plexus caused by incompetence of the valves in the internal spermatic vein. Varicocele has a prevalence of 10-15 % in the general population and is a common cause of male infertility, being present in 30-35% of men with primary, and 69-81% of men with secondary infertility. There is more than one approach to the treatment of varicocele associated MFI One common approach is to treat by assisted reproductive techniques (ART). Patients with a total motile sperm count of <10 million sperm are usually treated by IVF with or without ICSI. Fertilization of oocytes may be accomplished by isolating even a single adequate spermatozoa in the laboratory bypassing the majority of semen quality inadequacies in male factor infertility. The results of this treatment using fresh embryos with a maternal age of<35 are 46% pregnancies and 40% live births per cycle.

Alternatively, varicocele associated MFI can be treated by repairing the varicocele to improve sperm quality. Occlusion of the spermatic veins by surgical and radiological methods is commonly performed in these circumstances to improve fertility. A large body of literature exists demonstrating post-treatment improvements in semen parameters and sperm DNA quality as well as improved spontaneous pregnancy rates compared to no treatment. There are also studies demonstrating improved results of ART after varicocele repair.

Both approaches have their advocates. ART often provide a relatively quick result and have a known excellent track record for both pregnancy and live birth rates. Unfortunately, these techniques are not without risks such as ovarian hyperstimulation syndrome and procedural complications. Multiple pregnancies are common with increased risk of premature labour and low birth weight. In addition the treatments are expensive and multiple treatments increase the financial burden on the health care system.

Varicocele occlusion is a minor procedure. If performed radiologically, there is often immediate return to normal activity. The complication rate is very low, mostly due to radiological contrast medium allergy. Modern equipment and careful technique enable the procedure to be completed with very low radiation doses that are well below the level proven to have any adverse biological effect.

If varicocele repair can be demonstrated to improve pregnancy outcomes in varicocele related MFI by spontaneous pregnancies or by improving pregnancy and live birth rates per ART implantation, then there are compelling health care and economic reasons for incorporating it as an initial treatment.

At present there have been no well constructed randomized trials to compare the outcomes of these two approaches.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Patient complies to varicocele treatment indications as per ASRM 2014 guidelines

  1. Palpable varicocele on physical exam
  2. The female partner has normal fertility or a potentially treatable cause of infertility
  3. Male has abnormal semen parameters

Age of female partner < 35 years

Exclusion Criteria:

Sub-clinical varicocele

Isolated teratospermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Varicocele embolization before IVF
Participants will have catheterization and embolization of varicoceles six months before beginning IVF
Procedure: Varicocele embolization
Ultrasound guided right internal jugular vein access with placement of a vascular sheath. Fluoroscopically guided selective catheterization of the left and right (if bilateral) spermatic veins to the level of the inguinal ligament. Occlusion of the spermatic vein(s) by embolization coils and a sclerosing agent (sodium tetradecyl sulphate 3%).
Other Names:
  • Varicocele repair
  • Varicocele occlusion
No Intervention: IVF without varicocele embolization
Participants will proceed from enrollment directly to IVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: 25 months
The percentage of embryo transfers resulting in a live birth
25 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 18 months
The percentage of embryo transfers resulting in a clinical pregnancy ((ultrasound visualization of a gestational sac with heartbeat)
18 months
Transfers per clinical pregnancy
Time Frame: 18 months
Total transfers divided by total clinical pregnancies (excluding natural pregnancies) for each study group
18 months
Transfers per live birth
Time Frame: 25 months
Total transfers divided by total live births (excluding natural pregnancies) for each study group
25 months
Ongoing pregnancy rate
Time Frame: 18 months
Number of pregnancies (including natural) at 3 month time intervals
18 months
Ongoing live birth rate
Time Frame: 25 months
Number of live births (including natural) at 3 month time intervals
25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Anthony G Verstandig, MD, C
  • Principal Investigator: Ruth Ronn, MD, V

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZMCvarivf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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