InfertilityNCT02422134
Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)
A study testing Cytokine group in people with Infertility, run by Ibn Sina Hospital at 2 sites in Egypt.
Trial summary
It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium. 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?
- Cytokine group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2014to Jun 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
- all patients
Who cannot join
- above 40 years old
Trial locations and contacts
2 sites in 1 country.
About this study
It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.
Read the detailed description
The IVF embryo transfer media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and implantation rate in vitro so we decide to design a trial to compare the clinical outcome by sibling embryo to be transferred into 2 groups and the same culture condition but with one arm with Cytokine and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.
- Conditions
- Infertility
- Being tested
- Cytokine group
- Keywords
- Pregnancy, implantation, Cytokine
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine groupOther
Testing the efficacy of adding Cytokine to embryo transfer medium
| Study group | Role | What they receive |
|---|---|---|
| Cytokine plus Hyalurinan embryo transfer arm | Active comparator | To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium. Receives: Other: Cytokine group |
| Hyalurinan embryo transfer group | No intervention | To transfer the embryos using a Hyaluronan enriched medium only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate ( % )
Measured: 9 months
Secondary outcomes (1)
Implantation rate ( % )
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 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
- 400 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
- NCT02422134
- Sponsor's protocol ID
- Ibnsina IVF Sohag
- Status last verified
- Jun 2016
- First submitted
- 16 Apr 2015
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)
- ClinicalTrials.gov ID
- NCT02422134
- Acronym / sponsor ID
- Ibnsina IVF Sohag
- Conditions
- Infertility
- Keywords
- Pregnancy, implantation, Cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banon IVF Center Assiut, Egypt
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 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.
It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.
Detailed description
The IVF embryo transfer media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and implantation rate in vitro so we decide to design a trial to compare the clinical outcome by sibling embryo to be transferred into 2 groups and the same culture condition but with one arm with Cytokine 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytokine plus Hyalurinan embryo transfer arm | Active comparator | Other: Cytokine groupTo monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium. |
| Hyalurinan embryo transfer group | No intervention | –To transfer the embryos using a Hyaluronan enriched medium only |
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)
- above 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 |
|---|---|---|
| Cytokine groupTesting the efficacy of adding Cytokine to embryo transfer medium | Other | Cytokine plus Hyalurinan embryo transfer arm |
Primary outcome
Pregnancy rate ( % )
Time frame: 9 months
1 secondary outcome
Implantation rate ( % )
Time frame: 9 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 29 Jun 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 Cytokine group 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 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 29 Jun 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?
Pregnancy rate ( % ) (time frame: 9 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 29 Jun 2016; AzTrials last refreshed its copy on 31 Oct 2026.