Embryonic DevelopmentNCT04485806
Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.
A study testing GPS/LM, SPL/LM and GPS/PO in people with Embryonic Development and Infertility, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients undergoing ICSI. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Embryonic Development, Infertility
- What is being tested?
- GPS/LM, SPL/LM and GPS/PO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 10 Jan 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female age is ≤ 37 years old with ≥ 8 MII oocytes
- Males with normal semen parameters (WHO 2010).
- We conducted three experiments all with Siblings oocytes splits and all embryos
Who cannot join
- Oocyte or sperm donation.
- Sever male factor.
- Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Culture Media Microdroplet Geometry and Different Oil Overlay on Pre Implantation Embryonic Development in Dry Incubators: Prospective Randomized Study.
A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients undergoing ICSI.
Read the detailed description
Purpose:
to determine the effect of culture media microdroplet geometry of different culture dishes and oil overlay on the pre implantation embryo development in dry incubators
Method:
We used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same conditions.
statistical analysis done using SPSS version 23
- Conditions
- Embryonic Development, Infertility
- Being tested
- GPS/LM, SPL/LM, GPS/PO, SPL/PO
- Keywords
- dry incubator, Osmolality, Oil overlay, Microdrops
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPS/LMOther
Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay
SPL/LMOther
Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay
GPS/POOther
Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay
SPL/POOther
Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay
| Study group | Role | What they receive |
|---|---|---|
| GPS / LM versus SPL/LM | Other | to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with light mineral oil (LM). Receives: Other: GPS/LM; Other: SPL/LM |
| GPS/PO versus SPL/PO | Other | to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO). Receives: Other: GPS/PO; Other: SPL/PO |
| GPS/PO versus GPS/LM | Other | to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS). Receives: Other: GPS/LM; Other: GPS/PO |
| SPL/PO versus SPL/LM | Other | to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL). Receives: Other: SPL/LM; Other: SPL/PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation rate
Percentage of total blastocysts / Total cleaved embryos
Measured: 5-6 days after ICSI
High quality blast rate
Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.
Measured: 5-6 days after ICSI
Secondary outcomes (4)
Fertilization rate
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Measured: 16-19 hours of ICSI
Cleavage rate
Percentage of cleaved embryos/ total number of fertilized oocytes
Measured: 72 hours of ICSI
High quality D3 embryos
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Measured: 72 hours of ICSI
Good quality trophectoderm/inner cell mass
better grade than 3BB of blast embryos according to Gardner's criteria 1999
Measured: 5-6 days after ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Aug 2019
- Primary completion1 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryonic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effect of two different culture dishes with two different oil overlay which used in human embryos culturing through ICSI procedures on the pre implantaion embryonic development.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manar M Hozyen, MSc., Principal investigator, Ganin Fertility CenterAmr Elshimy, BSc., Principal investigator, Ganin Fertility CenterHanaa Elkhader, BSc., Principal investigator, Ganin Fertility CenterHosam Zaki, MSc., Study chair, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485806
- Sponsor's protocol ID
- MH0002
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Culture Media Microdroplet Geometry and Different Oil Overlay on Pre Implantation Embryonic Development in Dry Incubators: Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT04485806
- Acronym / sponsor ID
- MH0002
- Conditions
- Embryonic Development, Infertility
- Keywords
- dry incubator, Osmolality, Oil overlay, Microdrops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 24 Jul 2020 (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.
A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients undergoing ICSI.
Detailed description
Purpose:
to determine the effect of culture media microdroplet geometry of different culture dishes and oil overlay on the pre implantation embryo development in dry incubators
Method:
We used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same conditions.
statistical analysis done using SPSS version 23
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Effect of two different culture dishes with two different oil overlay which used in human embryos culturing through ICSI procedures on the pre implantaion embryonic development.
| Arm | Type | Receives |
|---|---|---|
| GPS / LM versus SPL/LM | Other | Other: GPS/LM, Other: SPL/LMto determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with light mineral oil (LM). |
| GPS/PO versus SPL/PO | Other | Other: GPS/PO, Other: SPL/POto determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO). |
| GPS/PO versus GPS/LM | Other | Other: GPS/LM, Other: GPS/POto determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS). |
| SPL/PO versus SPL/LM | Other | Other: SPL/LM, Other: SPL/POto determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL). |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female age is ≤ 37 years old with ≥ 8 MII oocytes
- Males with normal semen parameters (WHO 2010).
- We conducted three experiments all with Siblings oocytes splits and all embryos
Key exclusion criteria (3 listed)
- Oocyte or sperm donation.
- Sever male factor.
- Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.
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 |
|---|---|---|
| GPS/LMMedia microdroplet geometry (3D dishes) in combination with light mineral oil overlay | Other | GPS / LM versus SPL/LM, GPS/PO versus GPS/LM |
| SPL/LMMedia microdroplet geometry (2D dishes) in combination with light mineral oil overlay | Other | GPS / LM versus SPL/LM, SPL/PO versus SPL/LM |
| GPS/POMedia microdroplet geometry (3D dishes) in combination with Paraffin oil overlay | Other | GPS/PO versus GPS/LM, GPS/PO versus SPL/PO |
| SPL/POMedia microdroplet geometry (2D dishes) in combination with paraffin oil overlay | Other | GPS/PO versus SPL/PO, SPL/PO versus SPL/LM |
Primary outcome
Blastulation rate
Time frame: 5-6 days after ICSI
Percentage of total blastocysts / Total cleaved embryos
High quality blast rate
Time frame: 5-6 days after ICSI
Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.
4 secondary outcomes
Fertilization rate
Time frame: 16-19 hours of ICSI
Cleavage rate
Time frame: 72 hours of ICSI
High quality D3 embryos
Time frame: 72 hours of ICSI
Good quality trophectoderm/inner cell mass
Time frame: 5-6 days after ICSI
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 24 Jul 2020.
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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.
Manar M Hozyen, MSc. principal investigator
Ganin Fertility Center
Amr Elshimy, BSc. principal investigator
Ganin Fertility Center
Hanaa Elkhader, BSc. principal investigator
Ganin Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPS/LM, SPL/LM and GPS/PO in people with Embryonic Development and Infertility, run by Ganin Fertility Center 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 3 inclusion and 3 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 24 Jul 2020. 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. 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?
Blastulation rate (time frame: 5-6 days after ICSI). The study lists 2 primary outcomes in all. 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 24 Jul 2020.