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OpenTrials
Completed

NCT Number: NCT04310761

Retrospective Comparison of Pregnancy Outcome of Infertile Patients After Fresh and Warmed Single Blastocyst Transfer From 2014 to 2018.

The investigators retrospectively analysed the maternal and neonatal outcomes following a single fresh blastocyst transfer and a single warmed blastocyst transfer from procedures performed between 2014 and 2018 in a tertiary level university based fertility clinic.

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Key information

Sex eligibility

Female

Study type

Observational

About this study

Previous studies that analysed pregnancy outcomes in women who underwent frozen single blastocyst transfer have shown an increase rate of large for gestational age and very large for gestational age (Zhang et al., 2019),increased maternal risks of placenta accreta and pregnancy-induced hypertension (Ishihara et al.,2014),and lower risks of placenta previa, placental abruption, very pre-term birth, small for gestational age, and perinatal mortality (Sha, Yin, Cheng,& Massey, 2018) than fresh blastocyst transfer.

The main outcome of this study is to analyse the rate of live births with the relative gestational period and neonatal weight and still death and neonatal death per each single blastocyst transfer, both fresh and warmed. Secondary outcomes include the incidence of obstetric pathologies, gestational diabetes and pre-eclampsia, and defects of placentation.

The study database included all pregnancies occurred after both a single fresh and warmed blastocyst transfer between the five-year period from 2014 to 2018 at Humanitas Fertility Centre. The inclusion criteria were all patients, without any age limitations, which underwent either FIVET or ICSI and only transferred a single blastocyst. With regards to exclusion criteria, the following were considered: ovodonation, suspended cycles and embryos which were subjected to pre-implantation genetic testing.The investigator performed a comparison of maternal and neonatal outcomes in these pregnancies which occurred in the same period of time and in the same age-group of women.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infertile women, without any age limitations, which underwent either FIVET or ICSI and only transferred a single blastocyst (warmed or fresh).

Exclusion criteria

  • Ovodonation, suspended cycles, and embryos subjected to pre-implantation genetic testing.

Treatment and study plan

one single blastocyst transfer, both fresh and warmed

Procedure

Ultrasound guided transvaginal embryo transfer.

Primary outcomes

  1. Rate of live births

    Time frame: 5 years

    Rate of live births with the relative gestational period and neonatal weight and still death and neonatal death per each single blastocyst transfer, both fresh and warmed

Secondary outcomes

  1. Incidence of obstetric pathologies

    Time frame: 5 years

    Incidence of obstetric pathologies, gestational diabetes and pre-eclampsia, and defects of placentation.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 17, 2020
Registry last updated
Mar 17, 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.