Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome

Pregnancy Clinical Trial

— IAFACT  

Official title:

Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408547
• Other study ID #: IakentroFC
• Status: Completed
• Start date: January 3, 2014
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2020
• Source: Iakentro Fertility Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3512
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Women undergoing embryo transfer after IVF

Exclusion Criteria:

• Women with known embryo implantation issues

Related Conditions & MeSH terms

• IVF
• Pregnancy

Intervention

Device:
• embryo transfer catheter
undergoing embryo transfer

Locations

Country	Name	City	State
Greece	IAKENTRO Fertility Center	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Iakentro Fertility Centre

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. Epub 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Endometrial thickness	Endometrial thickness prior to embryo transfer	prior to embryo transfer
Secondary	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
Secondary	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
Secondary	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
Secondary	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