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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Primary Maternal and Neonatal Outcomes; Assisted Reproductive Technology

Intervention / Treatment
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* Procedure: one single blastocyst transfer, both fresh and warmed


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnancy population after one single blastocyst transfer<br>The data have been collected from the Humanitas Fertility Center' Department database (ART.it) from a period between 2014 and 2018. | Procedure: one single blastocyst transfer, both fresh and warmed<br>* Ultrasound guided transvaginal embryo transfer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of live births | 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of obstetric pathologies | Incidence of obstetric pathologies, gestational diabetes and pre-eclampsia, and defects of placentation. | 5 years |