Development of a Screening Tool for Difficult Embryo Transfers

Completed

• Conditions: Infertility
• Interventions: Procedure: Oocyte Pick Up; Procedure: Embryo Transfer

• Registration Number: NCT05701072
• Lead Sponsor: ART Fertility Clinics LLC

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-27
• Study Start: 2023-03-06
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• All women undergoing an ET is eligible.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Embryo Transfer	-
All participants	Oocyte Pick Up	-

Primary Outcome Measures

Name	Time	Method
Accuracy of the screening tool to predict difficult ET	Approximately 4 months
Prevalence of difficult ET	Approximately 4 months
Percentage of screening questionnaires suggesting a difficult ET	Approximately 4 months

Trial Locations

Locations (1)

ART Fertility Clinics LLC; 🇦🇪 Dubai, United Arab Emirates