NCT03630900

Brief Summary

Myriads of elements affect human embryo culture in vitro. These include, but not limited to, air quality, culture media, culture temperature, incubator humidity, pH, and O2 levels. O2 tension has been thoroughly investigated and, to date, 5% O2 level is superior to 20%. Reports showed that lowering the O2 from Day 3 of embryo culture seems to be physiological.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
487

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

August 24, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

August 10, 2018

Last Update Submit

July 14, 2019

Conditions

Embryo Culture

Outcome Measures

Primary Outcomes (1)

  • Ongoing Implantation rate

    number of sacs with a heartbeat after week twelve of gestation

    three months

Secondary Outcomes (2)

  • clinical and ongoing pregnancies

    three months

  • human embryo development in vitro

    three months

Study Arms (2)

Sequential O2 culture (5% then 2.5%)

EXPERIMENTAL

Embryo culture from day 0 to 3 in 5% O2 then split to either 5% or 2.5% O2 until Day 5 or 6.

Other: Sequential O2 Culture

5% O2 culture

NO INTERVENTION

Interventions

Sequential O2 CultureOTHER

We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)

Sequential O2 culture (5% then 2.5%)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ICSI cycles undergoing their first ICSI attempt

You may not qualify if:

  • ICSI cycles with a previous failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qena Fertility Center

Qina, Qena Governorate, 123456, Egypt

Location

Banon Assiut

Asyut, Egypt

Location

IbnSina IVF Center

Sohag, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 15, 2018

Study Start

August 24, 2018

Primary Completion

June 20, 2019

Study Completion

July 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)