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OpenTrials
Completed

NCT Number: NCT05701072

Development of a Screening Tool for Difficult Embryo Transfers

This study aims to investigate the accuracy of a proposed screening tool in identifying difficult embryo transfers (ETs) without doing a mock ET.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

ART Fertility Clinics LLC, Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

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About this study

So far there has never been a screening tool to identify difficult ETs without doing a mock ET. This is a prospective, longitudinal study including at least 200 ETs. All women undergo a speculum examination at the time of transvaginal oocyte pick-up (OPU), the screening questionnaire will be filled by the Physician doing the OPU procedure. On the day of real ET, the Physician doing the ET will be blinded for the screening result, and fill a second questionnaire after the ET. Combined with the Embryologist recorded parameters, this second questionnaire will be used to categorize ETs as difficult or normal. Participants will NOT undergo any procedures beyond their routine treatment. Once the targeted number of participants are recruited, the questionnaires will be matched to see the accuracy of the screening questionnaire to identify difficult ETs.

Identification of difficult ETs with a non-invasive, free of cost questionnaire can enable selective mock transfers and facilitate the real ET for patients, who would otherwise be only recognized on the day of real ET, after their embryos have been already thawed for transfer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All women undergoing an ET is eligible.

Exclusion criteria

  • No exclusion criteria, women can participate with multiple ET procedures.

Treatment and study plan

Oocyte Pick Up

Procedure

The screening questionnaire will be filled by the Physician doing the OPU. The screening questionnaire will be informed by the participant's history. Cervix will be visualized during routine vaginal cleansing for OPU, and its appearance (size, and deviation) will be recorded in the screening questionnaire after the OPU procedure. Finally, a screenshot of the ultrasound used for OPU, showing the cervix and cervical canal in the sagittal plane will be taken during routine procedure and saved in electronic chart.

Embryo transfer

Procedure

When the participants comes back for ET during her routine treatment, ET will be done in exactly the same way in routine treatment. Participant will not undergo any additional manipulation, intervention, nor the procedure will take longer. The Embryologist assisting the procedure will record the duration of the procedure, from the moment the Physician takes the outer ET catheter to his/her hand until he/she passes the cervix and calls for the inner catheter loaded with the embryo. Up on completion of the ET procedure as routine practice, the Physician will fill a questionnaire about the procedure.

Primary outcomes

  1. Prevalence of difficult ET

    Time frame: Approximately 4 months

  2. Percentage of screening questionnaires suggesting a difficult ET

    Time frame: Approximately 4 months

  3. Accuracy of the screening tool to predict difficult ET

    Time frame: Approximately 4 months

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2023
Registry last updated
Feb 3, 2025

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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