Clinical Outcomes of Slow Developing Blastocysts

NCT03360097 | Terminated DMC

• 1 other identifier: SMD-SLOW-2017-10
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

In vitro Fertilization; Slow Developing Blastocyst; Fresh Embryo Transfer; Frozen Embryo Transfer; Live Birth Rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Biochemical Pregnancy Rate

  9 days after date of embryo transfer

• Live Birth Rate

  24 weeks after the embryo transfer

• Miscarriage Rate

  14 weeks after the embryo transfer

• Cryopreservation-thaw rate

  1 day after the thawing procedure

Study Arms (2)

Fresh ET

NO INTERVENTION

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.

Frozen Embryo Transfer

EXPERIMENTAL

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

Interventions

Frozen Embryo Transfer PROCEDURE

Patient's embryos are cultured to day 6, vitrified and transferred in a cryo-synthetic cycle

Frozen Embryo Transfer

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Ovum Donation cycles
• Preimplantation genetic testing cycles

Sponsors & Collaborators

• Fundacion Dexeus: lead

Study Sites (1)

Institut Universitari Dexeus

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jorge Rodriguez-Purata, MD

  Fundacion Dexeus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 0.025

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 2, 2017
• Study Start: December 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2020
• Access Criteria: All

Locations

ES (1)