InfertilityNCT04888091
Comparison of the Effect of Cervical Mucus Cleaning Method Applied Before Embryo Transfer on Pregnancy Rates.
A study testing Cotton swab and Cannula in people with Infertility, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
To assess the impact of cervical mucus cleansing before embryo transfer and compare two different instruments for this purpose. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Cotton swab and Cannula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2021to 8 Jul 2022
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 21-40 years old women,
- Women undergoing good quality embryo transfer,
- Women who are eligible for a single or double embryo transfer.
Who cannot join
- If there is a diagnosis of a uterine anomaly,
- If there is a diagnosis of myoma uteri,
- If there is a diagnosis of rheumatological disease,
- Women to be transferred other than good quality embryo,
- Hİstory of previous pelvic, gynecological operation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Istanbul, 34668
About this study
Official title: The Effect of Two Different Cervical Mucus Removal Methods on Pregnancy Rates. 180 Cases Will be Randomized Into 3 Groups for Cervical Mucus Intervention. Removal With Cotton Swab, Removal With Cannula and Mucus Left on Cervix.
To assess the impact of cervical mucus cleansing before embryo transfer and compare two different instruments for this purpose.
Read the detailed description
All patients will be informed about the study and those who give written consent will be included in the study.
Women undergoing good quality embryo transfer will be assigned to one of the 3 arms of the study according to the previously determined randomization chart. The first evaluation of the patient will be made on the 12th day after embryo transfer. Pregnancy status will be evaluated with serum βhcg value. If pregnancy is confirmed by serum βhcg value, fetal viability will be evaluated by ultrasound 4 weeks after transfer.
- Conditions
- Infertility
- Being tested
- Cotton swab, Cannula
- Keywords
- Cervical mucus, Embryo transfer, Pregnancy rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotton swabProcedure or surgery
Removal of the cervical mucus with a cotton swab before embryo transfer.
CannulaProcedure or surgery
Removal of the cervical mucus with a cannula before embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Cervical mucus removal with cotton swab | Active comparator | Cervical mucus will be removed with cotton swab before embryo transfer Receives: Procedure: Cotton swab |
| Cervical mucus removal with cannula | Active comparator | Cervical mucus will be removed with cannula before embryo transfer Receives: Procedure: Cannula |
| No cervical mucus removal | No intervention | Cervical mucus will not be removed prior to embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting pregnancy after embryo transfer.
Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer.
Measured: 12 days after embryo transfer/ intervention.
Confirmation of fetal cardiac activity in detected pregnancy.
Evaluation of fetal cardiac activity on ultrasound.
Measured: 3-4 weeks after embryo transfer/ intervention.
Secondary outcomes (1)
Success of embryo transfer during intervention.
In some cases, the embryo is transferred to the endometrial cavity and comes back with the transfer cannula. For this reason, the embryology laboratory checks the transfer cannula after the transfer. If the embryo is still in the embryo transfer cannula, a second attempt is made for embryo transfer. As a secondary outcome, we will evaluate the success in the first attempt for embryo transfer.
Measured: 5 minutes after embryo transfer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start25 Jun 2021
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a parallel model interventional study. The sample size is calculated as 180 patients. Sixty patients will be assigned to each study arm by randomization. It is planned to use random computerized numbers for randomization. İn arm 1, cervical mucus will be removed with a cotton swab before embryo transfer. In arm 2, cervical mucus will be removed with a canula before embryo transfer. In arm 3, cervical mucus will not be removed.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enis ozkaya, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- Belgin Devranoğlu, Ass. Prof., Principal investigator, Zeynep Kamil Women and Children's Diseases Training and Research HospitalMüşerref Banu Yılmaz, Md., Study director, Zeynep Kamil Women and Children's Diseases Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888091
- Sponsor's protocol ID
- 90-07.April.2021
- Status last verified
- Feb 2024
- First submitted
- 3 May 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Cervical Mucus Removal Methods on Pregnancy Rates. 180 Cases Will be Randomized Into 3 Groups for Cervical Mucus Intervention. Removal With Cotton Swab, Removal With Cannula and Mucus Left on Cervix.
- ClinicalTrials.gov ID
- NCT04888091
- Acronym / sponsor ID
- 90-07.April.2021
- Conditions
- Infertility
- Keywords
- Cervical mucus, Embryo transfer, Pregnancy rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 17 May 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.
To assess the impact of cervical mucus cleansing before embryo transfer and compare two different instruments for this purpose.
Detailed description
All patients will be informed about the study and those who give written consent will be included in the study.
Women undergoing good quality embryo transfer will be assigned to one of the 3 arms of the study according to the previously determined randomization chart. The first evaluation of the patient will be made on the 12th day after embryo transfer. Pregnancy status will be evaluated with serum βhcg value. If pregnancy is confirmed by serum βhcg value, fetal viability will be evaluated by ultrasound 4 weeks after transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- It is a parallel model interventional study. The sample size is calculated as 180 patients. Sixty patients will be assigned to each study arm by randomization. It is planned to use random computerized numbers for randomization. İn arm 1, cervical mucus will be removed with a cotton swab before embryo transfer. In arm 2, cervical mucus will be removed with a canula before embryo transfer. In arm 3, cervical mucus will not be removed.
| Arm | Type | Receives |
|---|---|---|
| Cervical mucus removal with cotton swab | Active comparator | Procedure: Cotton swabCervical mucus will be removed with cotton swab before embryo transfer |
| Cervical mucus removal with cannula | Active comparator | Procedure: CannulaCervical mucus will be removed with cannula before embryo transfer |
| No cervical mucus removal | No intervention | –Cervical mucus will not be removed prior to embryo transfer |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 21-40 years old women,
- Women undergoing good quality embryo transfer,
- Women who are eligible for a single or double embryo transfer.
Key exclusion criteria (5 listed)
- If there is a diagnosis of a uterine anomaly,
- If there is a diagnosis of myoma uteri,
- If there is a diagnosis of rheumatological disease,
- Women to be transferred other than good quality embryo,
- Hİstory of previous pelvic, gynecological operation.
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 |
|---|---|---|
| Cotton swabRemoval of the cervical mucus with a cotton swab before embryo transfer. | Procedure or surgery | Cervical mucus removal with cotton swab |
| CannulaRemoval of the cervical mucus with a cannula before embryo transfer. | Procedure or surgery | Cervical mucus removal with cannula |
Primary outcome
Detecting pregnancy after embryo transfer.
Time frame: 12 days after embryo transfer/ intervention.
Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer.
Confirmation of fetal cardiac activity in detected pregnancy.
Time frame: 3-4 weeks after embryo transfer/ intervention.
Evaluation of fetal cardiac activity on ultrasound.
1 secondary outcome
Success of embryo transfer during intervention.
Time frame: 5 minutes after embryo transfer.
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 23 Feb 2024.
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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.
Belgin Devranoğlu, Ass. Prof. principal investigator
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Müşerref Banu Yılmaz, Md. study director
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cotton swab and Cannula in people with Infertility, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital 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 3 inclusion and 5 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 23 Feb 2024. 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.
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?
Detecting pregnancy after embryo transfer. (time frame: 12 days after embryo transfer/ intervention.). The study lists 2 primary outcomes in all. 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 23 Feb 2024.