Development of a Screening Tool for Difficult Embryo Transfers

NCT05701072 | Completed DMC

• 1 other identifier: 2208-ABU-007-BA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility

Keywords

infertility; embryo transfer

Outcome Measures

Primary Outcomes (3)

• Prevalence of difficult ET

  Approximately 4 months

• Percentage of screening questionnaires suggesting a difficult ET

  Approximately 4 months

• Accuracy of the screening tool to predict difficult ET

  Approximately 4 months

Study Arms (1)

All participants

Procedure: Oocyte Pick Up; Procedure: Embryo Transfer

Interventions

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.

All participants

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.

All participants

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women undergoing an ET in ART Fertility Clinics Abu Dhabi and Dubai.

You may qualify if:

• All women undergoing an ET is eligible.

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (2)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

Location

ART Fertility Clinics LLC

Dubai, United Arab Emirates

Location

Related Publications (7)

• Cirillo F, Patrizio P, Baccini M, Morenghi E, Ronchetti C, Cafaro L, Zannoni E, Baggiani A, Levi-Setti PE. The human factor: does the operator performing the embryo transfer significantly impact the cycle outcome? Hum Reprod. 2020 Feb 29;35(2):275-282. doi: 10.1093/humrep/dez290.

  PMID: 32100020 BACKGROUND

• Dessolle L, Freour T, Barriere P, Jean M, Ravel C, Darai E, Biau DJ. How soon can I be proficient in embryo transfer? Lessons from the cumulative summation test for learning curve (LC-CUSUM). Hum Reprod. 2010 Feb;25(2):380-6. doi: 10.1093/humrep/dep391. Epub 2009 Nov 18.

  PMID: 19923166 BACKGROUND

• Lopez MJ, Garcia D, Rodriguez A, Colodron M, Vassena R, Vernaeve V. Individualized embryo transfer training: timing and performance. Hum Reprod. 2014 Jul;29(7):1432-7. doi: 10.1093/humrep/deu080. Epub 2014 Apr 29.

  PMID: 24781427 BACKGROUND

• Noyes N, Licciardi F, Grifo J, Krey L, Berkeley A. In vitro fertilization outcome relative to embryo transfer difficulty: a novel approach to the forbidding cervix. Fertil Steril. 1999 Aug;72(2):261-5. doi: 10.1016/s0015-0282(99)00235-6.

  PMID: 10438992 BACKGROUND

• Kably Ambe A, Campos Canas JA, Aguirre Ramos G, Carballo Mondragon E, Carrera Lomas E, Ortiz Reyes H, Kisel Laska R. [Evaluation of two transfer embryo systems performed by six physicians]. Ginecol Obstet Mex. 2011 Apr;79(4):196-9. Spanish.

  PMID: 21966806 BACKGROUND

• Wood MA, Kerrigan KL, Burns MK, Glenn TL, Ludwin A, Christianson MS, Bhagavath B, Lindheim SR. Overcoming the Challenging Cervix: Identification and Techniques to Access the Uterine Cavity. Obstet Gynecol Surv. 2018 Nov;73(11):641-649. doi: 10.1097/OGX.0000000000000614.

  PMID: 30468239 BACKGROUND

• Ata B, Lawrenz B, Melado L, Del Gallego R, Coughlan C, Ruiz F, Marqueta Marques L, El-Damen A, Elkhatib I, Fatemi HM. The ART-ET screening tool: an easy-to-use non-invasive screening method to predict difficult embryo transfers in advance. Hum Reprod. 2025 Apr 1;40(4):647-653. doi: 10.1093/humrep/deaf002.

  PMID: 39938557 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Barbara Lawrenz, PhD

  ART Fertility Clinics LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 27, 2023
• Study Start: March 6, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

AE (2)