CompletedNCT03630848PCHEDUpdated Jun 11, 2020

Effect of Protein Concentration on Human Embryo Development

An interventional study of Effect of Protein on Blastocyst Development in Human Embryo Culture, sponsored by Ibn Sina Hospital. Completed at 2 sites in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Ibn Sina Hospital · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 1,536
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: Female

Study summary

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

Conditions studied

Human Embryo Culture

In context

Lead sponsor

Ibn Sina Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Intracytoplasmic sperm injection cycles

Exclusion criteria

Exclusion Criteria:

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,536 participants (actual)

Study arms

Experimental
10 mg/ml protein concentration in Embryo Culture Media
Other: Effect of Protein on Blastocyst Development
No intervention
5 mg/ml protein concentration in Embryo Culture Media

Interventions

OtherEffect of Protein on Blastocyst Development
Embryo Development Related to The Protein Concentration

What researchers measure

Primary outcomes

Ongoing pregnancy rate
Time frame: 12 weeks

Secondary outcomes

embryo development
Time frame: two months
Blastocyst Formation
number of formed blastocyst per fertilized oocyte
Time frame: two months
Clinical pregnancy rate
Time frame: 7 weeks
Implantation rate
Time frame: 7 weeks
Miscarriage rate
Time frame: 12 weeks

Study locations

2 sites

Banon Assiut
Assiut, Egypt
IbnSina IVF Center
Sohag, Egypt

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2018 to primary completion in Mar 2020, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 10, 2018
First posted: Aug 15, 2018
StartActual: Aug 14, 2018
Primary completionActual: Mar 2, 2020
CompletionActual: Mar 2, 2020
Last update: Jun 11, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03630848
Lead sponsor: Ibn Sina Hospital
Collaborators: Banon IVF Center Assiut, Egypt
Responsible party: Muhammad Fawzy (ivF Lab Director, Ibn Sina Hospital) — Principal investigator
First posted: Aug 15, 2018
Start date: Aug 14, 2018
Primary completion: Mar 2, 2020
Completion: Mar 2, 2020
Last update: Jun 11, 2020

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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