IVF Outcomes After Varicocele Repair

NCT03090438 | Unknown

• 1 other identifier: SZMCvarivf
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertility, Male; Varicocele; In Vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  The percentage of embryo transfers resulting in a live birth

  25 months

Secondary Outcomes (5)

• Pregnancy rate

  18 months

• Transfers per clinical pregnancy

  18 months

• Transfers per live birth

  25 months

• Ongoing pregnancy rate

  18 months

• Ongoing live birth rate

  25 months

Study Arms (2)

Varicocele embolization before IVF

ACTIVE COMPARATOR

Participants will have catheterization and embolization of varicoceles six months before beginning IVF

Procedure: Varicocele embolization

IVF without varicocele embolization

NO INTERVENTION

Participants will proceed from enrollment directly to IVF

Interventions

Varicocele embolization PROCEDURE

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%).

Also known as: Varicocele repair, Varicocele occlusion

Varicocele embolization before IVF

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient complies to varicocele treatment indications as per ASRM 2014 guidelines
• Palpable varicocele on physical exam
• The female partner has normal fertility or a potentially treatable cause of infertility
• Male has abnormal semen parameters
• Age of female partner \< 35 years

You may not qualify if:

• Sub-clinical varicocele
• Isolated teratospermia

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Related Publications (9)

• Gorelick JI, Goldstein M. Loss of fertility in men with varicocele. Fertil Steril. 1993 Mar;59(3):613-6.

  PMID: 8458466 BACKGROUND

• Agarwal A, Deepinder F, Cocuzza M, Agarwal R, Short RA, Sabanegh E, Marmar JL. Efficacy of varicocelectomy in improving semen parameters: new meta-analytical approach. Urology. 2007 Sep;70(3):532-8. doi: 10.1016/j.urology.2007.04.011.

  PMID: 17905111 BACKGROUND

• Diegidio P, Jhaveri JK, Ghannam S, Pinkhasov R, Shabsigh R, Fisch H. Review of current varicocelectomy techniques and their outcomes. BJU Int. 2011 Oct;108(7):1157-72. doi: 10.1111/j.1464-410X.2010.09959.x. Epub 2011 Mar 24.

  PMID: 21435155 BACKGROUND

• Verstandig AG, Shamieh B, Shraibman V, Raveh D. Radiation dose reduction in fluoroscopic procedures: left varicocele embolization as a model. Eur Radiol. 2015 Jun;25(6):1639-45. doi: 10.1007/s00330-014-3556-4. Epub 2014 Dec 19.

  PMID: 25523457 BACKGROUND

• Esteves SC, Roque M, Agarwal A. Outcome of assisted reproductive technology in men with treated and untreated varicocele: systematic review and meta-analysis. Asian J Androl. 2016 Mar-Apr;18(2):254-8. doi: 10.4103/1008-682X.163269.

  PMID: 26510504 BACKGROUND

• Kim KH, Lee JY, Kang DH, Lee H, Seo JT, Cho KS. Impact of surgical varicocele repair on pregnancy rate in subfertile men with clinical varicocele and impaired semen quality: a meta-analysis of randomized clinical trials. Korean J Urol. 2013 Oct;54(10):703-9. doi: 10.4111/kju.2013.54.10.703. Epub 2013 Oct 15.

  PMID: 24175046 BACKGROUND

• Schauer I, Madersbacher S, Jost R, Hubner WA, Imhof M. The impact of varicocelectomy on sperm parameters: a meta-analysis. J Urol. 2012 May;187(5):1540-7. doi: 10.1016/j.juro.2011.12.084. Epub 2012 Mar 14.

  PMID: 22425089 BACKGROUND

• Li F, Yamaguchi K, Okada K, Matsushita K, Ando M, Chiba K, Yue H, Fujisawa M. Significant improvement of sperm DNA quality after microsurgical repair of varicocele. Syst Biol Reprod Med. 2012 Oct;58(5):274-7. doi: 10.3109/19396368.2012.692431. Epub 2012 Jul 2.

  PMID: 22979920 BACKGROUND

• The influence of varicocele on parameters of fertility in a large group of men presenting to infertility clinics. World Health Organization. Fertil Steril. 1992 Jun;57(6):1289-93.

  PMID: 1601152 BACKGROUND

MeSH Terms

Conditions

Infertility, Male; Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anthony G Verstandig, MD

  C

  PRINCIPAL INVESTIGATOR

• Ruth Ronn, MD

  V

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony G Verstandig, MD

CONTACT

972 508685879; anthonyv@szmc.org.il

Ruth Ronn, MD

CONTACT

972 549964878; RuthRonn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2021
• Last Updated: March 24, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share