NCT02778217

Brief Summary

Culture media used to support development of zygotes to the blastocyst stage is based on two basic philosophies: a single step medium "let-the-embryo-choose" or a sequential medium "back-to-nature". For single step media, there are two types of protocol can be used for the culture of human preimplantation embryos:

  1. 1.Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo culture
  2. 2.Uninterrupted single embryo culture, in which the same single medium is used throughout the 5-6 days of culture with no replenishment or replacement on Day 3.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

May 17, 2016

Last Update Submit

June 10, 2016

Conditions

Sub-optimal Culture Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    diagnosed by the presence of a heartbeat in the gestational sac visualized by ultrasound

    4 weeks post embryo transfer

Secondary Outcomes (2)

  • Implantation rate

    4-6 weeks post embryo transfer

  • Blastocyst formation rate

    5-6 days post intracytoplasmic sperm injection

Study Arms (2)

Uninterrupted single embryo culture

NO INTERVENTION

The same single medium is used throughout the 5-6 days of culture with no replenishment on day 3.

Interrupted single medium culture

EXPERIMENTAL

The single step medium is renewed on Day 3 of embryo culture.

Procedure: Culture media renwal

Interventions

Culture media renwalPROCEDURE
Interrupted single medium culture

Eligibility Criteria

Age19 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female partners were under the age of 39 years
  • Intracytoplasmic sperm injection (ICSI) was performed using fresh ejaculates

You may not qualify if:

  • Day 3 embryo transfer cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunrise fertility center

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Costa-Borges N, Belles M, Meseguer M, Galliano D, Ballesteros A, Calderon G. Blastocyst development in single medium with or without renewal on day 3: a prospective cohort study on sibling donor oocytes in a time-lapse incubator. Fertil Steril. 2016 Mar;105(3):707-713. doi: 10.1016/j.fertnstert.2015.11.038. Epub 2015 Dec 12.

    PMID: 26690010RESULT

Study Officials

  • Yasmin Magdi, M.Sc

    Dar Almaraa fertility and gynacology center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmin Magdi, M.Sc

CONTACT

+201282313979Yas.magdi@hotmail.com

Ahmed El-Damen, M.Sc

CONTACT

+201002414342Ahmed_eldamen@Yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior clinical embryologist

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 19, 2016

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

EG(1)