Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome

NCT ID: NCT04408547

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3512 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-03
• Study Completion Date: 2019-12-30

Brief Summary

Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.

Detailed Description

Most patients undergoing IVF or ICSI reach a blastocyst embryo transfer but less achieve pregnancy and live birth. Many reasons have been proposed to explain these results. Among them, the factor Embryo Transfer Procedure gained less of the attention since few papers have been published and most of them had a lot of biases. In order to eliminate possible biases, we wanted to analyze our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.

Primary outcomes: bhCG positive rate, pregnancy rate, ongoing pregnancy rate, live birth rate.

Secondary outcomes: Full bladder, uterine ax orientation, Endometrial thickness, type of catheter, straightforward advancement of the preloaded catheter, use of a stiffer hard catheter to pass through the cervix and the orifice, the site of the uterine cavity that the embryo was released, single or double transfer due to blocked embryo in the catheter.

In addition for each embryo transfer variables that may influence the pregnancy rates will be collected: age of the woman, number of oocytes harvested, sperm characteristics, fertilization rate, stage and grade of the embryos the day of transfer

Conditions

IVF; Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

soft catheter

Patients who underwent embryo transfer with a soft catheter

embryo transfer catheter

Intervention Type: DEVICE

undergoing embryo transfer

stiff catheter

Patients who underwent embryo transfer with a stiff catheter because soft couldn't pass

embryo transfer catheter

Intervention Type: DEVICE

undergoing embryo transfer

Interventions

embryo transfer catheter

undergoing embryo transfer

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women undergoing embryo transfer after IVF

Exclusion Criteria

• Women with known embryo implantation issues

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Iakentro Fertility Centre

OTHER

Sponsor Role: lead

Responsible Party

Yannis Prapas

Professor of Obstetrics - Gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IAKENTRO Fertility Center

Thessaloniki, , Greece

Countries

Greece

References

Prapas N, Prapas Y, Panagiotidis Y, Prapa S, Vanderzwalmen P, Makedos G. Cervical dilatation has a positive impact on the outcome of IVF in randomly assigned cases having two previous difficult embryo transfers. Hum Reprod. 2004 Aug;19(8):1791-5. doi: 10.1093/humrep/deh320. Epub 2004 Jun 3.

Reference Type: RESULT

PMID: 15178658 (View on PubMed)

Other Identifiers

IakentroFC

Identifier Type: -

Identifier Source: org_study_id