InfertilityNCT04736459
Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination
A study testing Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination in people with Infertility, run by Eskisehir Osmangazi University.
Trial summary
The aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes. We know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 29 Jan 2021to 1 Jun 2021
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 1-year infertility
- at least one patent fallopian tube confirmed by hysterosalpingography (HSG) or laparoscopy
- ovulatory menstrual cycles
- suitable semen analysis according to the World Health Organization (WHO) criteria for intrauterine insemination
Who cannot join
- bilateral tubal occlusion
- mild or severe endometriosis
- day 3 serum FSH (follicle-stimulating hormone) > 13 IU/L
- abnormal thyroid function tests, hyperprolactinemia
- total motile sperm count (TMSC) < 5 millions or severe teratospermia (<4% normal forms) following semen preparation
- more than 3 follicles above the size of 17mm on the day of ovulation triggering
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination Have an Effect on Pregnancy Rates?
The aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes.
We know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. Based on this knowledge, we also constituted the hypothesis which is about the impact of washing the catheter on the gametes and embryos. The pre-washing the catheter before intrauterine insemination may provide higher pregnancy results.
- Conditions
- Infertility
- Being tested
- Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination
- Keywords
- intrauterine insemination, pre-washing catheter
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-washed catheter vs. Unwashed catheter in the intrauterine inseminationProcedure or surgery
The pre-washed catheter will be washed with culture medium before intrauterine insemination The unwashed catheter will not be washed with culture medium as a standard intrauterine insemination procedure
| Study group | Role | What they receive |
|---|---|---|
| Washed Catheter | Experimental | Washed catheter arm: will be washed with culture medium before insemination Receives: Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination |
| Unwashed Catheter | Sham comparator | Unwashed catheter arm: will not be washed with culture medium. Receives: Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy will be defined as the presence of a heartbeat at 6th gestational weeks
Measured: 8 weeks after intrauterine insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start29 Jan 2021 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vehbi Yavuz Tokgoz, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736459
- Sponsor's protocol ID
- 2222392979
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination Have an Effect on Pregnancy Rates?
- ClinicalTrials.gov ID
- NCT04736459
- Acronym / sponsor ID
- 2222392979
- Conditions
- Infertility
- Keywords
- intrauterine insemination, pre-washing catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 29 Jan 2021 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 3 Feb 2021 (actual)
- 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.
The aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes.
We know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. Based on this knowledge, we also constituted the hypothesis which is about the impact of washing the catheter on the gametes and embryos. The pre-washing the catheter before intrauterine insemination may provide higher pregnancy results.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Washed Catheter | Experimental | Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine inseminationWashed catheter arm: will be washed with culture medium before insemination |
| Unwashed Catheter | Sham comparator | Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine inseminationUnwashed catheter arm: will not be washed with culture medium. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- at least 1-year infertility
- at least one patent fallopian tube confirmed by hysterosalpingography (HSG) or laparoscopy
- ovulatory menstrual cycles
- suitable semen analysis according to the World Health Organization (WHO) criteria for intrauterine insemination
Key exclusion criteria (6 listed)
- bilateral tubal occlusion
- mild or severe endometriosis
- day 3 serum FSH (follicle-stimulating hormone) > 13 IU/L
- abnormal thyroid function tests, hyperprolactinemia
- total motile sperm count (TMSC) < 5 millions or severe teratospermia (<4% normal forms) following semen preparation
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 |
|---|---|---|
| Pre-washed catheter vs. Unwashed catheter in the intrauterine inseminationThe pre-washed catheter will be washed with culture medium before intrauterine insemination The unwashed catheter will not be washed with culture medium as a standard intrauterine insemination procedure | Procedure or surgery | Unwashed Catheter, Washed Catheter |
Primary outcome
Clinical pregnancy rate
Time frame: 8 weeks after intrauterine insemination
Clinical pregnancy will be defined as the presence of a heartbeat at 6th gestational weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination in people with Infertility, run by Eskisehir Osmangazi University.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vehbi Yavuz Tokgöz (+902222392979, mdtokgoz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 8 weeks after intrauterine insemination). 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 3 Feb 2021.