Clinical Outcomes of Slow Developing Blastocysts

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Procedure: Frozen Embryo Transfer

• Registration Number: NCT03360097
• Lead Sponsor: Institut Universitari Dexeus

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-27
• Study Start: 2017-12-01
• Study First Posted: 2017-12-02
• Status Verified: 2018-05
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frozen Embryo Transfer	Frozen Embryo Transfer	The best available embryo is at expansion grade \<4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and vitrified regardless of expansion grade. Arrested blastocysts are discarded. The single best available embryo is transferred under a cryo-synthetic cycle.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	20 days after date of embryo transfer	Proportion of patients with the presence of a gestational sac seen by transvaginal ultrasonography 20 days after the embryo transfer

Secondary Outcome Measures

Name	Time	Method
Biochemical Pregnancy Rate	9 days after date of embryo transfer	Proportion of patients with the detection of β-hCG level ≥5 mIU/mL 9 days after the embryo transfer
Live Birth Rate	24 weeks after the embryo transfer	Proportion of patients which deliver a live infant after 24 weeks of gestation
Miscarriage Rate	14 weeks after the embryo transfer	Proportion of patients with a pregnancy loss following a positive pregnancy test and/or detectable gestacional sac
Cryopreservation-thaw rate	1 day after the thawing procedure	Proportion of vitrified blastocysts which survive the re-warming

Trial Locations

Locations (1)

Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain