ContraceptionNCT00612833
A Randomized Controlled Trial of Three Vasectomy Techniques
A study testing Vasectomy occlusion techniques in people with Contraception, run by FHI 360 at 5 sites in India.
Trial summary
This study will be a randomized, controlled multicenter trial, conducted jointly by the Indian Council of Medical Research, New Delhi and Family Health International, which will compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV) approach to isolation of the vas: 1. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Contraception
- What is being tested?
- Vasectomy occlusion techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 5 sitesIndia
- Study dates
- Jan 2009to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Freely consent to participate in the study and sign an informed consent form
- Be at least 21 years old
- The couple should have at least one living child greater than one year of age
- With his partner be willing to use an alternate method of contraception until success is confirmed
- Be willing to return for follow-up visits at 1, 8, 12 and 52 weeks post-vasectomy, and at 16, 20 and 24 weeks if needed
- Be willing to submit semen samples collected by masturbation in the clinic according to the study follow-up schedule
- Be able to understand the procedures and study requirements
Who cannot join
- Has a condition that in the opinion of the investigator permanently or temporarily contraindicates participation in the study, e.g., depression or poorly-controlled diabetes
- History of surgery involving the vas or testes (including previous vasectomy)
- Previous injury or significant abnormality of the scrotum
- Clinical evidence of an acute sexually transmitted infection; however a man may be admitted to the study after resolution of the acute condition.
- Local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, but a man may be admitted after resolution of an acute infection
- History of coagulation or other bleeding disorders
Show all 9Show fewer
- Large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass
- Acute systemic infection (including gastroenteritis), but a man may be admitted after resolution of the condition
- Currently taking or planning to take any type of systemic medication which could affect sperm count (e.g. anabolic steroids)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Civil Hospital,
Amritsar, Punjab, 143 001
E. S.T.N.M. Hospital, Gangtok
Gangtok, Sikkim, 737 101
Maulana Azad Medical College
New Delhi, National Capital Territory of Delhi, 110 002
St. Stephens Hospital
New Delhi, National Capital Territory of Delhi, 110 054
Post Graduate Institute of Medical Sciences
Rohtak, Haryana, 124 001
About this study
This study will be a randomized, controlled multicenter trial, conducted jointly by the Indian Council of Medical Research, New Delhi and Family Health International, which will compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV) approach to isolation of the vas:
- ligation and excision of about 1 cm of the vas, with fascial interposition;
- intraluminal thermal cautery with excision of about 1 cm of the vas;
- intraluminal thermal cautery with excision of about 1 cm of the vas combined with fascial interposition.
A total of 1500 healthy, sexually active men at least 21 years old who have chosen vasectomy as a means of contraception will be recruited at four to six study sites in India. The success of the vasectomy procedure will be determined based on semen analysis results. All men should have semen analyses at 8 and 12 weeks post-vasectomy. All men will be asked to attend a final visit at 12 months.
Read the detailed description
This study will be a randomized, controlled multicenter trial, conducted jointly by the Indian Council of Medical Research, New Delhi and Family Health International, which will compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV) approach to isolation of the vas:
- ligation and excision of about 1 cm of the vas, with fascial interposition;
- intraluminal thermal cautery with excision of about 1 cm of the vas; and,
- intraluminal thermal cautery with excision of about 1 cm of the vas combined with fascial interposition.
A total of 1500 healthy, sexually active men at least 21 years old who have chosen vasectomy as a means of contraception will be recruited at four to six study sites in India. The success of the vasectomy procedure will be determined based on semen analysis results. All men should have semen analyses at 8 and 12 weeks post-vasectomy. All men will be asked to attend a final visit at 12 months.
- Conditions
- Contraception
- Being tested
- Vasectomy occlusion techniques
- Keywords
- Vasectomy, Male contraception, Contraceptive effectiveness, Semen analysis, Surgical techniques, Fascial interposition, Cautery, The relative contraceptive effectiveness of three methods of occluding the vas, in the context of a no-scalpel vasectomy procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasectomy occlusion techniquesProcedure or surgery
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
| Study group | Role | What they receive |
|---|---|---|
| cautery excision with fascial interposition | Active comparator | Contraception using cautery and excision with fascial interposition Receives: Procedure: Vasectomy occlusion techniques |
| B | Active comparator | Cautery and excision without fascial interposition Receives: Procedure: Vasectomy occlusion techniques |
| C | Active comparator | Ligation and excision with fascial interposition Receives: Procedure: Vasectomy occlusion techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm concentration in semen
Measured: 12 weeks
Secondary outcomes (1)
Safety
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startJan 2009
Why it stopped: FHI 360 participation in the study was terminated due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Sponsor
- Investigators
- Chander Shekhar, MD, Principal investigator, ICMRDavid C. Sokal, MD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612833
- Sponsor's protocol ID
- FHI-9980
- Status last verified
- Sep 2013
- First submitted
- 29 Jan 2008
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Three Vasectomy Techniques
- ClinicalTrials.gov ID
- NCT00612833
- Acronym / sponsor ID
- FHI-9980
- Conditions
- Contraception
- Keywords
- Vasectomy, Male contraception, Contraceptive effectiveness, Semen analysis, Surgical techniques, Fascial interposition, Cautery, The relative contraceptive effectiveness of three methods of occluding the vas, in the context of a no-scalpel vasectomy procedure.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FHI 360 participation in the study was terminated due to lack of funding
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- Jan 2009
- First posted
- 12 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a randomized, controlled multicenter trial, conducted jointly by the Indian Council of Medical Research, New Delhi and Family Health International, which will compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV) approach to isolation of the vas:
- ligation and excision of about 1 cm of the vas, with fascial interposition;
- intraluminal thermal cautery with excision of about 1 cm of the vas;
- intraluminal thermal cautery with excision of about 1 cm of the vas combined with fascial interposition.
A total of 1500 healthy, sexually active men at least 21 years old who have chosen vasectomy as a means of contraception will be recruited at four to six study sites in India. The success of the vasectomy procedure will be determined based on semen analysis results. All men should have semen analyses at 8 and 12 weeks post-vasectomy. All men will be asked to attend a final visit at 12 months.
Detailed description
This study will be a randomized, controlled multicenter trial, conducted jointly by the Indian Council of Medical Research, New Delhi and Family Health International, which will compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV) approach to isolation of the vas:
- ligation and excision of about 1 cm of the vas, with fascial interposition;
- intraluminal thermal cautery with excision of about 1 cm of the vas; and,
- intraluminal thermal cautery with excision of about 1 cm of the vas combined with fascial interposition.
A total of 1500 healthy, sexually active men at least 21 years old who have chosen vasectomy as a means of contraception will be recruited at four to six study sites in India. The success of the vasectomy procedure will be determined based on semen analysis results. All men should have semen analyses at 8 and 12 weeks post-vasectomy. All men will be asked to attend a final visit at 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cautery excision with fascial interposition | Active comparator | Procedure: Vasectomy occlusion techniquesContraception using cautery and excision with fascial interposition |
| B | Active comparator | Procedure: Vasectomy occlusion techniquesCautery and excision without fascial interposition |
| C | Active comparator | Procedure: Vasectomy occlusion techniquesLigation and excision with fascial interposition |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Freely consent to participate in the study and sign an informed consent form
- Be at least 21 years old
- The couple should have at least one living child greater than one year of age
- With his partner be willing to use an alternate method of contraception until success is confirmed
- Be willing to return for follow-up visits at 1, 8, 12 and 52 weeks post-vasectomy, and at 16, 20 and 24 weeks if needed
Key exclusion criteria (9 listed)
- Has a condition that in the opinion of the investigator permanently or temporarily contraindicates participation in the study, e.g., depression or poorly-controlled diabetes
- History of surgery involving the vas or testes (including previous vasectomy)
- Previous injury or significant abnormality of the scrotum
- Clinical evidence of an acute sexually transmitted infection; however a man may be admitted to the study after resolution of the acute condition.
- Local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, but a man may be admitted after resolution of an acute infection
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 |
|---|---|---|
| Vasectomy occlusion techniquesCautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition | Procedure or surgery | B, C, cautery excision with fascial interposition |
Primary outcome
Sperm concentration in semen
Time frame: 12 weeks
1 secondary outcome
Safety
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: FHI 360 participation in the study was terminated due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- Related InfoLink provided by the sponsor.
Related trials for Contraception
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
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.
Chander Shekhar, MD principal investigator
ICMR
David C. Sokal, MD principal investigator
FHI 360
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasectomy occlusion techniques in people with Contraception, run by FHI 360 at 5 sites in India.
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 7 inclusion and 9 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 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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.
Are results available for this study?
The study was stopped early (reason given: FHI 360 participation in the study was terminated due to lack of funding). Results are not available in the source record.
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?
Sperm concentration in semen (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2013.