Human Embryo CulturePCHEDNCT03630848
Effect of Protein Concentration on Human Embryo Development
A study testing Effect of Protein on Blastocyst Development in people with Human Embryo Culture, run by Ibn Sina Hospital at 2 sites in Egypt.
Trial summary
Protein Concentration in Human Embryo Culture Media remains assigned to the manufacturers with no clear evidence on which concentration is ideal. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Human Embryo Culture
- What is being tested?
- Effect of Protein on Blastocyst Development
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,536 participants
- Where
- 2 sitesEgypt
- Study dates
- 14 Aug 2018to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Intracytoplasmic sperm injection cycles
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Protein Concentration and Human Embryo Development
Protein Concentration in Human Embryo Culture Media remains assigned to the manufacturers with no clear evidence on which concentration is ideal.
- Conditions
- Human Embryo Culture
- Being tested
- Effect of Protein on Blastocyst Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Protein on Blastocyst DevelopmentOther
Embryo Development Related to The Protein Concentration
| Study group | Role | What they receive |
|---|---|---|
| 10 mg/ml protein concentration in Embryo Culture Media | Experimental | Not described Receives: Other: Effect of Protein on Blastocyst Development |
| 5 mg/ml protein concentration in Embryo Culture Media | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Measured: 12 weeks
Secondary outcomes (5)
embryo development
Measured: two months
Blastocyst Formation
number of formed blastocyst per fertilized oocyte
Measured: two months
Clinical pregnancy rate
Measured: 7 weeks
Implantation rate
Measured: 7 weeks
Miscarriage rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start14 Aug 2018
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Embryo CultureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Banon IVF Center Assiut, Egypt
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630848
- Sponsor's protocol ID
- IbnSina IVFCenter-Protein
- Acronym
- PCHED
- Status last verified
- Jun 2020
- First submitted
- 10 Aug 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Concentration and Human Embryo Development
- ClinicalTrials.gov ID
- NCT03630848
- Acronym / sponsor ID
- PCHED / IbnSina IVFCenter-Protein
- Conditions
- Human Embryo Culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,536 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banon IVF Center Assiut, Egypt
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protein Concentration in Human Embryo Culture Media remains assigned to the manufacturers with no clear evidence on which concentration is ideal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Intracytoplasmic sperm injection cycles
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of Protein on Blastocyst DevelopmentEmbryo Development Related to The Protein Concentration | Other | 10 mg/ml protein concentration in Embryo Culture Media |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks
5 secondary outcomes
embryo development
Time frame: two months
Blastocyst Formation
Time frame: two months
Clinical pregnancy rate
Time frame: 7 weeks
Implantation rate
Time frame: 7 weeks
Miscarriage rate
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Protein on Blastocyst Development in people with Human Embryo Culture, run by Ibn Sina Hospital at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.