InfertilityNCT02420171
Adding Insulin to IVF Culture Media Significantly Improve Outcome
A study testing Adding insulin to In Vitro culture media in people with Infertility, run by Ibn Sina Hospital at 2 sites in Egypt.
Trial summary
Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential. 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
- Infertility
- What is being tested?
- Adding insulin to In Vitro culture media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2015to Dec 2015
- 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
- normal responder
- PCOS
- Tubal factor infertility
- mild asthenozoospermia
Who cannot join
- patient over 40
Trial locations and contacts
2 sites in 1 country.
About this study
Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.
Read the detailed description
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding insulin as a hormon and growth factor 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 yhe same culture condition but with one arm with insulin and the other is traditional one and closely monitor the outcome within the 2 arms abd record the results
- Conditions
- Infertility
- Being tested
- Adding insulin to In Vitro culture media
- Keywords
- In Vitro, embryo quality, Intracytoplasmic sperm injection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding insulin to In Vitro culture mediaOther
We will add insulin for in vitro culture of human embryos
| Study group | Role | What they receive |
|---|---|---|
| In Vitro culture media with insulin | Active comparator | We will add insulin to the single step culture media to monitor the embryogenesis Receives: Other: Adding insulin to In Vitro culture media |
| In Vitro culture media without insulin m | No intervention | The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical Pregnancy rate ( % )
Measured: 6 months
Secondary outcomes (2)
Blastocyst rate ( % )
Measured: 6 months
Blastocyst quality rate ( % )
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- None (open label)
- Enrolment
- 360 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
- NCT02420171
- Sponsor's protocol ID
- Ibnsina IVF center Sohag
- Status last verified
- Jul 2016
- First submitted
- 14 Apr 2015
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Insulin to IVF Culture Media Significantly Improve Outcome
- ClinicalTrials.gov ID
- NCT02420171
- Acronym / sponsor ID
- Ibnsina IVF center Sohag
- Conditions
- Infertility
- Keywords
- In Vitro, embryo quality, Intracytoplasmic sperm injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banon IVF Center Assiut, Egypt
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 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.
Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.
Detailed description
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding insulin as a hormon and growth factor 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 yhe same culture condition but with one arm with insulin and the other is traditional one and closely monitor the outcome within the 2 arms abd record the results
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Vitro culture media with insulin | Active comparator | Other: Adding insulin to In Vitro culture mediaWe will add insulin to the single step culture media to monitor the embryogenesis |
| In Vitro culture media without insulin m | No intervention | –The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- normal responder
- PCOS
- Tubal factor infertility
- mild asthenozoospermia
Key exclusion criteria (1 listed)
- patient over 40
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 |
|---|---|---|
| Adding insulin to In Vitro culture mediaWe will add insulin for in vitro culture of human embryos | Other | In Vitro culture media with insulin |
Primary outcome
clinical Pregnancy rate ( % )
Time frame: 6 months
2 secondary outcomes
Blastocyst rate ( % )
Time frame: 6 months
Blastocyst quality rate ( % )
Time frame: 6 months
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 13 Jul 2016.
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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 Adding insulin to In Vitro culture media in people with Infertility, 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 4 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 13 Jul 2016. 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?
clinical Pregnancy rate ( % ) (time frame: 6 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 13 Jul 2016.