Blastocyst Culture in a Time-lapse Incubator

NCT ID: NCT02778217

Last Updated: 2016-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Brief Summary

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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. Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo culture
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.

Investigators aim to compare the blastocyst development and clinical outcome between the two types of protocols of a single medium (with or without renewal on Day 3)

Detailed Description

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Conditions

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Sub-optimal Culture Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Uninterrupted single embryo culture

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interrupted single medium culture

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

Group Type EXPERIMENTAL

Culture media renwal

Intervention Type PROCEDURE

Interventions

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Culture media renwal

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Day 3 embryo transfer cycles
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dar AlMaraa Center

OTHER

Sponsor Role lead

Responsible Party

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Yasmin

Senior clinical embryologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasmin Magdi, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Dar Almaraa fertility and gynacology center

Locations

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Sunrise fertility center

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yasmin Magdi, M.Sc

Role: CONTACT

+201282313979

Ahmed El-Damen, M.Sc

Role: CONTACT

+201002414342

Facility Contacts

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Dr.Sherif Basha Sief, MD

Role: primary

0020238517677

References

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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.

Reference Type RESULT
PMID: 26690010 (View on PubMed)

Other Identifiers

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006734

Identifier Type: -

Identifier Source: org_study_id

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