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

NCT ID: NCT04310761

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4613 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-12-31

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.

Conditions

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Primary Maternal and Neonatal Outcomes; Assisted Reproductive Technology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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pregnancy population after one single blastocyst transfer

The data have been collected from the Humanitas Fertility Center' Department database (ART.it) from a period between 2014 and 2018.

one single blastocyst transfer, both fresh and warmed

Intervention Type PROCEDURE

Ultrasound guided transvaginal embryo transfer.

Interventions

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one single blastocyst transfer, both fresh and warmed

Ultrasound guided transvaginal embryo transfer.

Intervention Type PROCEDURE

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Zhang J, Wang Y, Liu H, Mao X, Chen Q, Fan Y, Xiao Y, Kuang Y. Effect of in vitro culture period on birth weight after vitrified-warmed transfer cycles: analysis of 4,201 singleton newborns. Fertil Steril. 2019 Jan;111(1):97-104. doi: 10.1016/j.fertnstert.2018.10.006. Epub 2018 Nov 17.

Reference Type BACKGROUND
PMID: 30458993 (View on PubMed)

Ishihara O, Araki R, Kuwahara A, Itakura A, Saito H, Adamson GD. Impact of frozen-thawed single-blastocyst transfer on maternal and neonatal outcome: an analysis of 277,042 single-embryo transfer cycles from 2008 to 2010 in Japan. Fertil Steril. 2014 Jan;101(1):128-33. doi: 10.1016/j.fertnstert.2013.09.025. Epub 2013 Oct 23.

Reference Type BACKGROUND
PMID: 24268706 (View on PubMed)

Sha T, Yin X, Cheng W, Massey IY. Pregnancy-related complications and perinatal outcomes resulting from transfer of cryopreserved versus fresh embryos in vitro fertilization: a meta-analysis. Fertil Steril. 2018 Feb;109(2):330-342.e9. doi: 10.1016/j.fertnstert.2017.10.019. Epub 2018 Jan 11.

Reference Type BACKGROUND
PMID: 29331236 (View on PubMed)

Cirillo F, Grilli L, Ronchetti C, Paladino I, Morenghi E, Busnelli A, Levi-Setti PE. Retrospective comparison of pregnancy outcomes of fresh and frozen-warmed single blastocyst transfer: a 5-year single-center experience. J Assist Reprod Genet. 2022 Jan;39(1):201-209. doi: 10.1007/s10815-021-02362-3. Epub 2021 Nov 26.

Reference Type DERIVED
PMID: 34837160 (View on PubMed)

Other Identifiers

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XX/2020

Identifier Type: -

Identifier Source: org_study_id

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