Development of a Screening Tool for Difficult Embryo Transfers

Infertility Clinical Trial

Official title:

Development of a Screening Tool for Difficult Embryo Transfers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701072
• Other study ID #: 2208-ABU-007-BA
• Status: Recruiting
• Start date: March 6, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: November 2023
• Source: ART Fertility Clinics LLC
• Contact: Barbara Lawrenz, PhD
• Phone: +97126528000
• Email: barbara.lawrenz[@]artfertilityclinics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2024
• Est. primary completion date: December 30, 2023
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All women undergoing an ET is eligible.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Oocyte Pick Up
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
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.

Locations

Country	Name	City	State
United Arab Emirates	ART Fertility Clinics LLC	Abu Dhabi
United Arab Emirates	ART Fertility Clinics LLC	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
ART Fertility Clinics LLC

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of difficult ET		Approximately 4 months
Primary	Percentage of screening questionnaires suggesting a difficult ET		Approximately 4 months
Primary	Accuracy of the screening tool to predict difficult ET		Approximately 4 months