NCT03630848

Brief Summary

Protein Concentration in Human Embryo Culture Media remains assigned to the manufacturers with no clear evidence on which concentration is ideal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,536

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 10, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 14, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.6 years

First QC Date

August 10, 2018

Last Update Submit

June 9, 2020

Conditions

Human Embryo Culture

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    12 weeks

Secondary Outcomes (5)

  • embryo development

    two months

  • Blastocyst Formation

    two months

  • Clinical pregnancy rate

    7 weeks

  • Implantation rate

    7 weeks

  • Miscarriage rate

    12 weeks

Study Arms (2)

10 mg/ml protein concentration in Embryo Culture Media

EXPERIMENTAL
Other: Effect of Protein on Blastocyst Development

5 mg/ml protein concentration in Embryo Culture Media

NO INTERVENTION

Interventions

Effect of Protein on Blastocyst DevelopmentOTHER

Embryo Development Related to The Protein Concentration

10 mg/ml protein concentration in Embryo Culture Media

Eligibility Criteria

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

You may qualify if:

  • Intracytoplasmic sperm injection cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banon Assiut

Asyut, Egypt

Location

IbnSina IVF Center

Sohag, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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 14, 2018

Primary Completion

March 2, 2020

Study Completion

March 2, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)