InfertilityPhase 1/2NCT02265055
Early Embryo Cleavage And Multiple Pregnancies After ICSI
A Phase 1/2 study testing transfer early cleavage embryos and transfer non early cleavage embryo in people with Infertility, run by Al-Azhar University.
Trial summary
To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI. Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- transfer early cleavage embryos and transfer non early cleavage embryo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 2012
- Phase
- Phase 1/2
- 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 Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- BMI >25 - 30 kg/m2
- Have two ovaries
- Regular cycles
- first ICSI cycle
- Long midluteal GnRH protocol.
Who cannot join
- uterine factor as a cause of female factor infertility
- pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...)
- history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...)
- azoospermia as a cause of male factor infertility
About this study
To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.
Read the detailed description
A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study.
The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).
- Conditions
- Infertility
- Being tested
- transfer early cleavage embryos, transfer non early cleavage embryo
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transfer early cleavage embryosProcedure or surgery
transfer early cleavage embryos
transfer non early cleavage embryoProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| transfer early cleavage embryos (EC) | Active comparator | transfer early cleavage embryos Receives: Procedure: transfer early cleavage embryos |
| transfer non early cleavage embryo (NEC) | Active comparator | transfer non early cleavage embryos Receives: Procedure: transfer non early cleavage embryo |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy
Measured: 6 weeks
Secondary outcomes (1)
multiple pregnancy
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startDec 2010
- Primary completionSep 2012
- Study completionDec 2012
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 1/2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edessy Mahmoud, Al-Azhar University
- Investigators
- mahmoud edessy, prof, Study director, Al-Azhar Universityabd elnasr m ali, prof, Principal investigator, Al-Azhar Universityahmed fata, prof, Principal investigator, Al-Azhar Universitywael hamed, dr, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265055
- Sponsor's protocol ID
- u12345
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Embryo Cleavage And Multiple Pregnancies After ICSI
- ClinicalTrials.gov ID
- NCT02265055
- Acronym / sponsor ID
- u12345
- Conditions
- Infertility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Oct 2014 (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.
To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.
Detailed description
A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study.
The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transfer early cleavage embryos (EC) | Active comparator | Procedure: transfer early cleavage embryostransfer early cleavage embryos |
| transfer non early cleavage embryo (NEC) | Active comparator | Procedure: transfer non early cleavage embryotransfer non early cleavage embryos |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- BMI >25 - 30 kg/m2
- Have two ovaries
- Regular cycles
- first ICSI cycle
- Long midluteal GnRH protocol.
Key exclusion criteria (4 listed)
- uterine factor as a cause of female factor infertility
- pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...)
- history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...)
- azoospermia as a cause of male factor infertility
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 |
|---|---|---|
| transfer early cleavage embryostransfer early cleavage embryos | Procedure or surgery | transfer early cleavage embryos (EC) |
| transfer non early cleavage embryo | Procedure or surgery | transfer non early cleavage embryo (NEC) |
Primary outcome
clinical pregnancy
Time frame: 6 weeks
1 secondary outcome
multiple pregnancy
Time frame: 8 weeks
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 15 Oct 2014.
Related trials for Infertility
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
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.
mahmoud edessy, prof study director
Al-Azhar University
abd elnasr m ali, prof principal investigator
Al-Azhar University
ahmed fata, prof principal investigator
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing transfer early cleavage embryos and transfer non early cleavage embryo in people with Infertility, run by Al-Azhar University.
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 5 inclusion and 4 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 15 Oct 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: 6 weeks). 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 15 Oct 2014.