LATEBLOOM: Clinical Outcomes of Slow Developing Blastocysts

Sponsor

Institut Universitari Dexeus (Other)

Overall Status

Terminated

CT.gov ID

NCT03360097

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: Frozen Embryo Transfer	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All participants will be randomized by an intention to treat approach. Randomization at the blastocyst stage is chosen to avoid cycle cancellation if randomized earlier. All components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list. An interim analysis is planned and sample size will be plan accordingly, under the Pocok method, including 2 stages, with p-value as boundary scale, calculated to have 80% power to detect a 20% difference with a reference proportion of 25% clinical pregnancy rate and a one-sided (upper) alpha of 0.025All participants will be randomized by an intention to treat approach. Randomization at the blastocyst stage is chosen to avoid cycle cancellation if randomized earlier. All components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list. An interim analysis is planned and sample size will be plan accordingly, under the Pocok method, including 2 stages, with p-value as boundary scale, calculated to have 80% power to detect a 20% difference with a reference proportion of 25% clinical pregnancy rate and a one-sided (upper) alpha of 0.025

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

May 30, 2018

Actual Study Completion Date :

May 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Universitari Dexeus	Barcelona		Spain	08022

Sponsors and Collaborators

Institut Universitari Dexeus

Investigators

Principal Investigator: Jorge Rodriguez-Purata, MD, Institut Universitari Dexeus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jorge Rodriguez-Purata, Principal Investigator, Institut Universitari Dexeus

ClinicalTrials.gov Identifier:

NCT03360097

Other Study ID Numbers:

SMD-SLOW-2017-10

First Posted:

Dec 2, 2017

Last Update Posted:

Jun 1, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jorge Rodriguez-Purata, Principal Investigator, Institut Universitari Dexeus

In vitro Fertilization

Slow Developing Blastocyst

Fresh Embryo Transfer

Frozen Embryo Transfer

Live Birth Rate

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Jun 1, 2018