Clinical Outcomes of Slow Developing Blastocysts (LATEBLOOM)

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

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.

Study Overview

• Status: Terminated
• Conditions: Infertility
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Institut Universitari Dexeus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Fresh ET; 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 transferred regardless of expansion grade. Arrested blastocysts are discarded.
Experimental: 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.	Procedure: Frozen Embryo Transfer; Patient's embryos are cultured to day 6, vitrified and transferred in a cryo-synthetic cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical Pregnancy Rate	Proportion of patients with the detection of β-hCG level ≥5 mIU/mL 9 days after the embryo transfer	9 days after date of embryo transfer
Live Birth Rate	Proportion of patients which deliver a live infant after 24 weeks of gestation	24 weeks after the embryo transfer
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
Cryopreservation-thaw rate	Proportion of vitrified blastocysts which survive the re-warming	1 day after the thawing procedure

Collaborators and Investigators

• Sponsor: Institut Universitari Dexeus

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Frozen Embryo Transfer; In vitro Fertilization; Slow Developing Blastocyst; Fresh Embryo Transfer; Live Birth Rate
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: SMD-SLOW-2017-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all collected IPD
• IPD Sharing Time Frame: January 2020
• IPD Sharing Access Criteria: All
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No