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

Primary Maternal and Neonatal Outcomes; Assisted Reproductive Technology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310761
• Other study ID #: XX/2020
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2020
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4613
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Primary Maternal and Neonatal Outcomes; Assisted Reproductive Technology

Intervention

Procedure:
• one single blastocyst transfer, both fresh and warmed
Ultrasound guided transvaginal embryo transfer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

References & Publications (3)

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. Erratum in: Fertil Steril. 2014 Apr;101(4):1200. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of obstetric pathologies	Incidence of obstetric pathologies, gestational diabetes and pre-eclampsia, and defects of placentation.	5 years