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NCT Number: NCT04408547

Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome

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.

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Key information

Conditions

IVF Pregnancy

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

IAKENTRO Fertility Center

Thessaloniki, 542 50, Greece

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women undergoing embryo transfer after IVF

Exclusion criteria

  • Women with known embryo implantation issues

Treatment and study plan

embryo transfer catheter

Device

undergoing embryo transfer

Primary outcomes

  1. Number of patients with bhCG positive test after embryo transfer

    Time frame: Number of patients bhCG positive up to12 days after embryo transfer

    Number of patients bhCG positive up to12 days after embryo transfer

  2. Number of patients with on going clinical pregnancy

    Time frame: Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer

    Number of patients with on going clinical pregnancy up to12 weeks after embryo transfer

  3. Number of live births after embryo transfer

    Time frame: Number oflive birth up to 9 months after embryo transfer

    Number oflive birth up to9 months after embryo transfer

Secondary outcomes

  1. Percentage of fullnes of bladder

    Time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer

    Percentage of fullness of the bladder during embryo transfer

  2. Endometrial thickness

    Time frame: prior to embryo transfer

    Endometrial thickness prior to embryo transfer

  3. Uterine axe orientation

    Time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer

    Uterine axe orientation during embryo transfer

  4. Type of embryo transfer catheter

    Time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer

    Type of embryo transfer catheter used in the procedure

  5. Distance from the fundus of the embryo release

    Time frame: 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

  6. Embryo retained in the catheter

    Time frame: 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

    Embryo retained in the catheter

Sponsors and collaborators

Lead sponsor

Iakentro Fertility Centre

Other

Registry information

Acronym: IAFACT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 29, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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