Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome (IAFACT)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; IVF
• Intervention / Treatment: Device: embryo transfer catheter

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

• Study Type: Observational
• Enrollment (Actual): 3512

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 542 50
    • IAKENTRO Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing embryo transfer after IVF

Description

Inclusion Criteria:

• Women undergoing embryo transfer after IVF

Exclusion Criteria:

• Women with known embryo implantation issues

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
soft catheter; Patients who underwent embryo transfer with a soft catheter	Device: embryo transfer catheter; undergoing embryo transfer
stiff catheter; Patients who underwent embryo transfer with a stiff catheter because soft couldn't pass	Device: embryo transfer catheter; undergoing embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with bhCG positive test after embryo transfer	Number of patients bhCG positive up to12 days after embryo transfer	Number of patients bhCG positive up to12 days after embryo transfer
Number of patients with on going clinical pregnancy	Number of patients with on going clinical pregnancy up to12 weeks after embryo transfer	Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer
Number of live births after embryo transfer	Number oflive birth up to9 months after embryo transfer	Number oflive birth up to 9 months after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of fullnes of bladder	Percentage of fullness of the bladder during embryo transfer	At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Endometrial thickness	Endometrial thickness prior to embryo transfer	prior to embryo transfer
Uterine axe orientation	Uterine axe orientation during embryo transfer	At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Type of embryo transfer catheter	Type of embryo transfer catheter used in the procedure	At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Distance from the fundus of the embryo release	Distance from the fundus of the embryo release	At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Embryo retained in the catheter	Embryo retained in the catheter	Number of patients who underwent embryo transfer and the embryo was retained in the catheter at the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer

Collaborators and Investigators

• Sponsor: Iakentro Fertility Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2014
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IakentroFC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No