InfertilityPhase 2NCT01999959
Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment
A Phase 2 study testing Pertubation in people with Infertility and Pertubation, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Infertility, Pertubation, Insemination
- What is being tested?
- Pertubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Jun 2011
- Phase
- Phase 2
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on HSG; sperm concentration >15 million spermatozoa/ml and total sperm number >39 million/ml according to WHO criteria
Who cannot join
- the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.
- Conditions
- Infertility, Pertubation, Insemination
- Being tested
- Pertubation
- Keywords
- Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertubationProcedure or surgery
a lavage procedure of the intrauterine cavity and bilateral fallopian tubes
| Study group | Role | What they receive |
|---|---|---|
| Pertubation performed | Experimental | Study group had pertubation and insemination Receives: Procedure: Pertubation |
| Pertubation not performed | No intervention | Study group had insemination only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnancy rate at 6 month-follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Gazi 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Korkmaz, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999959
- Sponsor's protocol ID
- 3061750
- Status last verified
- Nov 2013
- First submitted
- 26 Nov 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
Publications
Yildiz F, Bozkurt N, Erdem A, Erdem M, Oktem M, Onur Karabacak R. Effect of Pertubation on Pregnancy Rates before Intrauterine Insemination Treatment in Patients with Unexplained Infertility. Int J Fertil Steril. 2014 Apr;8(1):77-84. Epub 2014 Mar 9.
PubMed 24695882
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment
- ClinicalTrials.gov ID
- NCT01999959
- Acronym / sponsor ID
- 3061750
- Conditions
- Infertility, Pertubation, Insemination
- Keywords
- Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Dec 2013 (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.
To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pertubation performed | Experimental | Procedure: PertubationStudy group had pertubation and insemination |
| Pertubation not performed | No intervention | –Study group had insemination only |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on HSG; sperm concentration >15 million spermatozoa/ml and total sperm number >39 million/ml according to WHO criteria
Key exclusion criteria (1 listed)
- the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding
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 |
|---|---|---|
| Pertubationa lavage procedure of the intrauterine cavity and bilateral fallopian tubes | Procedure or surgery | Pertubation performed |
Primary outcome
Pregnancy rate
Time frame: 6 months
Pregnancy rate at 6 month-follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
- Derived from this study: PubMed 24695882Yildiz F, Bozkurt N, Erdem A, Erdem M, Oktem M, Onur Karabacak R. Effect of Pertubation on Pregnancy Rates before Intrauterine Insemination Treatment in Patients with Unexplained Infertility. Int J Fertil Steril. 2014 Apr;8(1):77-84. Epub 2014 Mar 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pertubation in people with Infertility and Pertubation, run by Gazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pregnancy rate (time frame: 6 months). 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 NCT01999959, 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 3 Dec 2013.