Invitro FertilizationNCT02764255
Embryoscope and Reproductive Outcome
An observational study of Invitro Fertilization, run by Ahmed Maged.
Trial summary
cases with embyos cultured in the standard incubator and evaluated only by morphology are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Invitro Fertilization
- How many people
- 770 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2017
- Phase
- Observational
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Study population: 770 women undergoing ICSI cycles
Who may be able to join
- Patient age:25-40 years old
- BMI:18-30
- patients with first or second ICSI trial
Who cannot join
- AMH <1
- severe male factor(total motile sperm <1 million)
- frozen embryo transfer cycles
- patients with endocrinopathies or thrombophilia
- patients on medical treatment which may interfere with results
- hydrosalpinx
About this study
Official title: Does Embryoscope Improve Reproductive Outcome in ICSI Patients
cases with embyos cultured in the standard incubator and evaluated only by morphology are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model
Read the detailed description
cases with embyos cultured in the standard incubator and evaluated only by morphology (control group) are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model(study group)
- Conditions
- Invitro Fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| embryoscope group | cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model | |
| control group | cases with embyos cultured in the standard incubator and evaluated only by morphology |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
transvaginal ultrasound done to assess the gestational sac
Measured: 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invitro FertilizationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Maged
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764255
- Sponsor's protocol ID
- 146
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Embryoscope Improve Reproductive Outcome in ICSI Patients
- ClinicalTrials.gov ID
- NCT02764255
- Acronym / sponsor ID
- 146
- Conditions
- Invitro Fertilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Ahmed MagedUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 6 May 2016 (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.
cases with embyos cultured in the standard incubator and evaluated only by morphology are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model
Detailed description
cases with embyos cultured in the standard incubator and evaluated only by morphology (control group) are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model(study group)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| embryoscope group | – | –cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model |
| control group | – | –cases with embyos cultured in the standard incubator and evaluated only by morphology |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 770 women undergoing ICSI cycles
Key inclusion criteria (3 listed)
- Patient age:25-40 years old
- BMI:18-30
- patients with first or second ICSI trial
Key exclusion criteria (6 listed)
- AMH <1
- severe male factor(total motile sperm <1 million)
- frozen embryo transfer cycles
- patients with endocrinopathies or thrombophilia
- patients on medical treatment which may interfere with results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical pregnancy rate
Time frame: 14 days after embryo transfer
transvaginal ultrasound done to assess the gestational sac
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 25 Jul 2017.
- 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.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
Questions about this trial
What is this clinical trial studying?
An observational study of Invitro Fertilization, run by Ahmed Maged.
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 6 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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: 14 days after embryo transfer). 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 25 Jul 2017; AzTrials last refreshed its copy on 29 Oct 2026.