In Vitro Human Embryo DevelopmentGFSSSCMNCT02426008
Improving Embryogenesis by Adding Growth Factors to In Vitro Human Culture Media
A study testing Growth Factors and Cytokine adding to embryo culture media in people with In Vitro Human Embryo Development, run by Ibn Sina Hospital at 1 site in Egypt.
Trial summary
The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In Vitro Human Embryo Development
- What is being tested?
- Growth Factors and Cytokine adding to embryo culture media
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2015to Mar 2016
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- all patients
Who cannot join
- over 40 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growth Factors Supplementation to Single-Step Culture Medium
The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring.
Read the detailed description
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth factors to Lifeglobal culture media might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and the same culture condition but with one arm with growth factors and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.
- Conditions
- In Vitro Human Embryo Development
- Being tested
- Growth Factors and Cytokine adding to embryo culture media, No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Factors and Cytokine adding to embryo culture mediaOther
No InterventionOther
Nothing to Add
| Study group | Role | What they receive |
|---|---|---|
| Culture media with growth factors and Cytokine | Experimental | Growth factors and Cytokine adding to culture media to detect the deference and monitor the embryological outcome. Receives: Other: Growth Factors and Cytokine adding to embryo culture media |
| In Vitro culture media | Placebo comparator | culture media to monitor the embryological outcome as control group Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy rate ( % )
Measured: 3 months
Secondary outcomes (2)
ongoing Pregnancy rate ( % )
Measured: 6 months
rates of blastocyst formation and quality
Measured: 6 days of culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start1 May 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro Human Embryo DevelopmentStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 426 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
- NCT02426008
- Sponsor's protocol ID
- IbnSina IVF
- Acronym
- GFSSSCM
- Status last verified
- Sep 2018
- First submitted
- 17 Apr 2015
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Factors Supplementation to Single-Step Culture Medium
- ClinicalTrials.gov ID
- NCT02426008
- Acronym / sponsor ID
- GFSSSCM / IbnSina IVF
- Conditions
- In Vitro Human Embryo Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banon IVF Center Assiut, Egypt
- Study start
- 1 May 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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.
The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring.
Detailed description
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth factors to Lifeglobal culture media might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and the same culture condition but with one arm with growth factors and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culture media with growth factors and Cytokine | Experimental | Other: Growth Factors and Cytokine adding to embryo culture mediaGrowth factors and Cytokine adding to culture media to detect the deference and monitor the embryological outcome. |
| In Vitro culture media | Placebo comparator | Other: No Interventionculture media to monitor the embryological outcome as control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients
Key exclusion criteria (1 listed)
- over 40 years old
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 |
|---|---|---|
| Growth Factors and Cytokine adding to embryo culture media | Other | Culture media with growth factors and Cytokine |
| No InterventionNothing to Add | Other | In Vitro culture media |
Primary outcome
Clinical Pregnancy rate ( % )
Time frame: 3 months
2 secondary outcomes
ongoing Pregnancy rate ( % )
Time frame: 6 months
rates of blastocyst formation and quality
Time frame: 6 days of culture
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 2 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Factors and Cytokine adding to embryo culture media in people with In Vitro Human Embryo Development, run by Ibn Sina Hospital at 1 site 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Clinical Pregnancy rate ( % ) (time frame: 3 months). 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 2 Oct 2018.