Clinical trial NCT04408547: Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome
Official title: Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IVF
Pregnancy
Lead sponsor: Iakentro Fertility Centre
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 3512
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing embryo transfer after IVF

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

Eligibility criteria: Inclusion Criteria:

* Women undergoing embryo transfer after IVF

Exclusion Criteria:

* Women with known embryo implantation issues

Primary outcomes:
measure: Number of patients with bhCG positive test after embryo transfer
timeFrame: Number of patients bhCG positive up to12 days after embryo transfer
measure: Number of patients with on going clinical pregnancy
timeFrame: Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer
measure: Number of live births after embryo transfer
timeFrame: Number oflive birth up to 9 months after embryo transfer
Secondary outcomes:
measure: Percentage of fullnes of bladder
timeFrame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
measure: Endometrial thickness
timeFrame: prior to embryo transfer
measure: Uterine axe orientation
timeFrame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
measure: Type of embryo transfer catheter
timeFrame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
measure: Distance from the fundus of the embryo release
timeFrame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
measure: Embryo retained in the catheter
timeFrame: 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
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: IAKENTRO Fertility Center
Study officials:
References:
citation: 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.