Clinical Outcomes of Slow Developing Blastocysts

Infertility Clinical Trial

— LATEBLOOM  

Official title:

Pregnancy Outcomes in Patients With Slow Developing Blastocysts: What is the Best Transfer Strategy? A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03360097
• Other study ID #: SMD-SLOW-2017-10
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2018
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. All cycles will be cultured to day 6 and half the patients will undergo a fresh embryo transfer and the other half a frozen embryo transfer.

Description:

A lack of established markers for predicting blastocyst development increases the risk of having no embryos or embryos not-fully expanded available for transfer. Slower but non-arrested embryos are frequently found to have progressed to blastocyst stage by the time of a day 6 transfer. In the absence of a receptive endometrium, embryo selection for fresh transfer may be futile, and cryopreservation could be a better option. The objective is to determine which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. The investigators hypothesize that in bad prognosis patients with slow-developing blastocysts, vitrified-warmed embryo transfer will result in higher implantation, clinical and ongoing pregnancy and live birth rates than fresh embryo transfer.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• All IVF cycles undergoing autologous fresh blastocyst embryo transfer

• All IVF cycles in which the best available embryo for transfer is at expansion grade <4

• All ages

Exclusion Criteria:

• Ovum Donation cycles

• Preimplantation genetic testing cycles

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Frozen Embryo Transfer
Patient's embryos are cultured to day 6, vitrified and transferred in a cryo-synthetic cycle

Locations

Country	Name	City	State
Spain	Institut Universitari Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy Rate	Proportion of patients with the presence of a gestational sac seen by transvaginal ultrasonography 20 days after the embryo transfer	20 days after date of embryo transfer
Secondary	Biochemical Pregnancy Rate	Proportion of patients with the detection of ß-hCG level =5 mIU/mL 9 days after the embryo transfer	9 days after date of embryo transfer
Secondary	Live Birth Rate	Proportion of patients which deliver a live infant after 24 weeks of gestation	24 weeks after the embryo transfer
Secondary	Miscarriage Rate	Proportion of patients with a pregnancy loss following a positive pregnancy test and/or detectable gestacional sac	14 weeks after the embryo transfer
Secondary	Cryopreservation-thaw rate	Proportion of vitrified blastocysts which survive the re-warming	1 day after the thawing procedure