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Completed

NCT Number: NCT04888091

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

To assess the impact of cervical mucus cleansing before embryo transfer and compare two different instruments for this purpose.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Cotton swab

Procedure

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

Cannula

Procedure

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

Primary outcomes

  1. 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.

  2. Confirmation of fetal cardiac activity in detected pregnancy.

    Time frame: 3-4 weeks after embryo transfer/ intervention.

    Evaluation of fetal cardiac activity on ultrasound.

Secondary outcomes

  1. Success of embryo transfer during intervention.

    Time frame: 5 minutes after embryo transfer.

    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.

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2021
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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