PregnancyPhase 3VIANCT00767338
Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis
A Phase 3 study testing Timed intercourse, Microsurgical varicocelectomy and Intrauterine insemination in people with Pregnancy and Infertility, run by Yale University at 9 sites in United States.
Trial summary
The primary research hypothesis is that microsurgical varicocelectomy will result in an increase in live birth in infertile couples where the male partner has a palpable varicocele and an abnormal semen analysis in comparison to male partners who do not have microsurgical varicocelectomy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Pregnancy, Infertility
- What is being tested?
- Timed intercourse, Microsurgical varicocelectomy and Intrauterine insemination
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2010to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 6 months of infertility (primary or secondary - randomization will be stratified to allow equal numbers of primary and secondary infertility couples in the treatment vs. observation group), male partner > 18 years of age and < 50 years of age
- Female partner > 18 years of age and <= 40 years of age - randomization will be stratified for two groups - female partner <35 and female partner >=35
- Evidence of a hysterosalpingogram or Saline Infusion Sonogram with one patent tube and regular ovulatory cycles as defined by the recruiting site >25 days and <35 days in duration in the female partner
- Evidence of a bilateral grade I or unilateral grade II-III varicocele on physical exam in the male partner
- Abnormal semen analysis as defined by WHO II criteria with a sperm count of >5 X106 /ml or the presence of abnormal strict morphology as defined by Kruger criteria.
Who cannot join
- The presence of retrograde ejaculation or uncorrectable ejaculatory dysfunction
- Decreased ovarian reserve in the female partner as evidence by a day #3 FSH > 12 mIU/ml
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
University of Vermont
Burlington, Vermont, 05405
Wayne State University
Detroit, Michigan, 48201
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, 17033
Yale University
New Haven, Connecticut, 06511
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07601
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
About this study
Official title: A Prospective, Randomized, Study of Microsurgical Varicocelectomy Versus Observation in the Treatment of Male Partners With a Palpable Varicocele and an Abnormal Semen Analysis
The primary research hypothesis is that microsurgical varicocelectomy will result in an increase in live birth in infertile couples where the male partner has a palpable varicocele and an abnormal semen analysis in comparison to male partners who do not have microsurgical varicocelectomy.
The secondary hypotheses include:
Read more
- To assess whether up to 4 cycles of intrauterine insemination confers any additional increase in live birth rates compared to timed intercourse;
- To examine spousal pregnancy rate as the secondary outcome; and
- To study the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele on
- Testicular semen analysis parameters;
- Serological measures of FSH, LH, total and free testosterone and
- Measures of quality of life and sexual function in both partners.
Read the detailed description
Study Design
This will be a randomized controlled clinical trial to examine the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele. This approach will allow us to compare (i) the effect of microsurgical varicocelectomy on live birth rates after up to four cycles of alternating intrauterine insemination and four cycles of timed intercourse over 8 months and (ii) the relative effectiveness of intrauterine insemination versus timed intercourse on live birth rates. Secondary analyses will explore the effect of the surgical intervention on pregnancy rates, semen analysis parameters, serological hormonal measures in the male subjects, and quality of life measures in both the male and female partners.
Treatment
Two hundred and thirty-two couples will be randomized to the two intervention groups (microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse or no microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse).
Timing
We anticipate that it will take 3 years to complete the study. Enrollment will begin in year 1 of the study. 34 couples will need to be recruited per site over the duration of the study to reach the enrollment goal of 232 couples. Participants will be enrolled in the study for one year, with the male partner undergoing periodic study assessments at two month intervals.
- Conditions
- Pregnancy, Infertility
- Being tested
- Timed intercourse, Microsurgical varicocelectomy, Intrauterine insemination
- Keywords
- Infertility, Pregnancy, Men, Palpable varicocele, Abnormal semen analysis, Intrauterine insemination, Microsurgical varicocelectomy
- Medical subject headings
- Infertility, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timed intercourseBehavioural
Also called TI
Timed intercourse
Microsurgical varicocelectomyProcedure or surgery
Also called Surgery
Microsurgical varicocelectomy
Intrauterine inseminationProcedure or surgery
Also called IUI
Intrauterine insemination
| Study group | Role | What they receive |
|---|---|---|
| No surgery + IUI | Active comparator | No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. Receives: Behavioral: Timed intercourse; Procedure: Intrauterine insemination |
| No Surgery + TI | Active comparator | No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse. Receives: Behavioral: Timed intercourse; Procedure: Intrauterine insemination |
| Surgery + IUI | Active comparator | Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. Receives: Behavioral: Timed intercourse; Procedure: Microsurgical varicocelectomy; Procedure: Intrauterine insemination |
| Surgery + TI | Active comparator | Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse. Receives: Behavioral: Timed intercourse; Procedure: Microsurgical varicocelectomy; Procedure: Intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Live Births After Eight Cycles of Infertility Treatment.
Measured: January 2009 to January 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: The DSMB recommended stopping the study because of concerns about the dismal recruitment, the drain on network resources, and the need for a study redesign.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Colorado, Denver, University of Michigan, University of Pennsylvania, University of Texas, University of Vermont, Wayne State University
- Responsible party
- Principal investigator, Heping Zhang, Yale University
- Investigators
- Esther Eisenberg, MD, MPH, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Nanette Santoro, MD, Study chair, Albert Einstein College of MedicineGregory M Christman, MD, Principal investigator, University of MichiganDana A Ohl, MD, Principal investigator, University of MichiganRichard Legro, MD, Study director, Pennsylvania State University College of MedicineRobert Brzyski, MD, PhD, Study director, The University of Texas Health Science Center at San AntonioPeter Casson, MD, Study director, University of VermontMichael Diamond, MD, Study director, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767338
- Sponsor's protocol ID
- RMN-VIA
- Other IDs
- 5U10HD055925-02, 5U10HD055936
- Acronym
- VIA
- Status last verified
- Jun 2013
- First submitted
- 3 Oct 2008
- Last updated
- 2 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Trussell JC, Christman GM, Ohl DA, Legro RS, Krawetz SA, Snyder PJ, Patrizio P, Polotsky AJ, Diamond MP, Casson PR, Coutifaris C, Barnhart K, Brzyski RG, Schlaff WD, Meacham R, Shin D, Thomas T, Zhang M, Santoro N, Eisenberg E, Zhang H; Reproductive Medicine Network. Recruitment challenges of a multicenter randomized controlled varicocelectomy trial. Fertil Steril. 2011 Dec;96(6):1299-305. doi: 10.1016/j.fertnstert.2011.10.025.
PubMed 22130101
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Study of Microsurgical Varicocelectomy Versus Observation in the Treatment of Male Partners With a Palpable Varicocele and an Abnormal Semen Analysis
- ClinicalTrials.gov ID
- NCT00767338
- Acronym / sponsor ID
- VIA / RMN-VIA
- Conditions
- Pregnancy, Infertility
- Keywords
- Infertility, Pregnancy, Men, Palpable varicocele, Abnormal semen analysis, Intrauterine insemination, Microsurgical varicocelectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The DSMB recommended stopping the study because of concerns about the dismal recruitment, the drain on network resources, and the need for a study redesign.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Colorado, Denver, University of Michigan, University of Pennsylvania, University of Texas, University of Vermont, Wayne State University
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Posted 8 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary research hypothesis is that microsurgical varicocelectomy will result in an increase in live birth in infertile couples where the male partner has a palpable varicocele and an abnormal semen analysis in comparison to male partners who do not have microsurgical varicocelectomy.
The secondary hypotheses include:
- To assess whether up to 4 cycles of intrauterine insemination confers any additional increase in live birth rates compared to timed intercourse;
- To examine spousal pregnancy rate as the secondary outcome; and
- To study the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele on
- Testicular semen analysis parameters;
- Serological measures of FSH, LH, total and free testosterone and
- Measures of quality of life and sexual function in both partners.
Detailed description
Study Design
This will be a randomized controlled clinical trial to examine the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele. This approach will allow us to compare (i) the effect of microsurgical varicocelectomy on live birth rates after up to four cycles of alternating intrauterine insemination and four cycles of timed intercourse over 8 months and (ii) the relative effectiveness of intrauterine insemination versus timed intercourse on live birth rates. Secondary analyses will explore the effect of the surgical intervention on pregnancy rates, semen analysis parameters, serological hormonal measures in the male subjects, and quality of life measures in both the male and female partners.
Treatment
Two hundred and thirty-two couples will be randomized to the two intervention groups (microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse or no microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse).
Timing
We anticipate that it will take 3 years to complete the study. Enrollment will begin in year 1 of the study. 34 couples will need to be recruited per site over the duration of the study to reach the enrollment goal of 232 couples. Participants will be enrolled in the study for one year, with the male partner undergoing periodic study assessments at two month intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No surgery + IUI | Active comparator | Behavioral: Timed intercourse, Procedure: Intrauterine inseminationNo microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. |
| No Surgery + TI | Active comparator | Behavioral: Timed intercourse, Procedure: Intrauterine inseminationNo microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse. |
| Surgery + IUI | Active comparator | Behavioral: Timed intercourse, Procedure: Microsurgical varicocelectomy, Procedure: Intrauterine inseminationMicrosurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. |
| Surgery + TI | Active comparator | Behavioral: Timed intercourse, Procedure: Microsurgical varicocelectomy, Procedure: Intrauterine inseminationMicrosurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 6 months of infertility (primary or secondary - randomization will be stratified to allow equal numbers of primary and secondary infertility couples in the treatment vs. observation group), male partner > 18 years of age and < 50 years of age
- Female partner > 18 years of age and <= 40 years of age - randomization will be stratified for two groups - female partner <35 and female partner >=35
- Evidence of a hysterosalpingogram or Saline Infusion Sonogram with one patent tube and regular ovulatory cycles as defined by the recruiting site >25 days and <35 days in duration in the female partner
- Evidence of a bilateral grade I or unilateral grade II-III varicocele on physical exam in the male partner
- Abnormal semen analysis as defined by WHO II criteria with a sperm count of >5 X106 /ml or the presence of abnormal strict morphology as defined by Kruger criteria.
Key exclusion criteria (2 listed)
- The presence of retrograde ejaculation or uncorrectable ejaculatory dysfunction
- Decreased ovarian reserve in the female partner as evidence by a day #3 FSH > 12 mIU/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timed intercourseAlso: TITimed intercourse | Behavioural | No Surgery + TI, No surgery + IUI, Surgery + IUI, Surgery + TI |
| Microsurgical varicocelectomyAlso: SurgeryMicrosurgical varicocelectomy | Procedure or surgery | Surgery + IUI, Surgery + TI |
| Intrauterine inseminationAlso: IUIIntrauterine insemination | Procedure or surgery | No Surgery + TI, No surgery + IUI, Surgery + IUI, Surgery + TI |
Primary outcome
Number of Live Births After Eight Cycles of Infertility Treatment.
Time frame: January 2009 to January 2012
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22130101Trussell JC, Christman GM, Ohl DA, Legro RS, Krawetz SA, Snyder PJ, Patrizio P, Polotsky AJ, Diamond MP, Casson PR, Coutifaris C, Barnhart K, Brzyski RG, Schlaff WD, Meacham R, Shin D, Thomas T, Zhang M, Santoro N, Eisenberg E, Zhang H; Reproductive Medicine Network. Recruitment challenges of a multicenter randomized controlled varicocelectomy trial. Fertil Steril. 2011 Dec;96(6):1299-305. doi: 10.1016/j.fertnstert.2011.10.025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Eisenberg, MD, MPH study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD study chair
Albert Einstein College of Medicine
Gregory M Christman, MD principal investigator
University of Michigan
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Timed intercourse, Microsurgical varicocelectomy and Intrauterine insemination in people with Pregnancy and Infertility, run by Yale University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Live Births After Eight Cycles of Infertility Treatment. (time frame: January 2009 to January 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00767338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.