ClinicalTrials.gg
CompletedNCT04888091Updated Feb 23, 2024

Comparison of the Effect of Cervical Mucus Cleaning Method Applied Before Embryo Transfer on Pregnancy Rates.

An interventional study of Cotton swab and Cannula in Infertility, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Completed at 1 site in Turkey. Open to female participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
183
Allocation
Randomized
Ages
21 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Infertility

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Keywords

  • Cervical mucus
  • Embryo transfer
  • Pregnancy rate
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 183 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 21-40 years old women,
  • Women undergoing good quality embryo transfer,
  • Women who are eligible for a single or double embryo transfer.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
183 participants (actual)

Study arms

  • Active comparator
    Cervical mucus removal with cotton swab

    Cervical mucus will be removed with cotton swab before embryo transfer

    Procedure: Cotton swab

  • Active comparator
    Cervical mucus removal with cannula

    Cervical mucus will be removed with cannula before embryo transfer

    Procedure: Cannula

  • No intervention
    No cervical mucus removal

    Cervical mucus will not be removed prior to embryo transfer

Interventions

  • ProcedureCotton swab

    Removal of the cervical mucus with a cotton swab before embryo transfer.

  • ProcedureCannula

    Removal of the cervical mucus with a cannula before embryo transfer.

06

What researchers measure

Primary outcomes

  1. Detecting pregnancy after embryo transfer.

    Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer.

    Time frame: 12 days after embryo transfer/ intervention.

  2. Confirmation of fetal cardiac activity in detected pregnancy.

    Evaluation of fetal cardiac activity on ultrasound.

    Time frame: 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.

    Time frame: 5 minutes after embryo transfer.

07

Study locations

1 site
  • Zeynep Kamil Women and Children's Diseases Training and Research Hospital
    Istanbul, 34668, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Jul 2022, 12 months.

Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 12 months is below that.

Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2021
First posted
May 17, 2021
StartActual
Jun 25, 2021
Primary completionActual
Jul 8, 2022
CompletionActual
Jul 8, 2022
Last update
Feb 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04888091
Lead sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Responsible party
enis ozkaya (Associate Professor, Specialist in Obstetrics and Gynecology, Zeynep Kamil Maternity and Pediatric Research and Training Hospital) — Principal investigator
First posted
May 17, 2021
Start date
Jun 25, 2021
Primary completion
Jul 8, 2022
Completion
Jul 8, 2022
Last update
Feb 23, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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