Sub-optimal Culture ConditionsNCT02778217
Blastocyst Culture in a Time-lapse Incubator
A study testing Culture media renwal in people with Sub-optimal Culture Conditions, run by Dar AlMaraa Center at 1 site in Egypt.
Trial summary
Culture media used to support development of zygotes to the blastocyst stage is based on two basic philosophies: a single step medium "let-the-embryo-choose" or a sequential medium "back-to-nature". For single step media, there are two types of protocol can be used for the culture of human preimplantation embryos: 1. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Sub-optimal Culture Conditions
- What is being tested?
- Culture media renwal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Jan 2017
- 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 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female partners were under the age of 39 years
- Intracytoplasmic sperm injection (ICSI) was performed using fresh ejaculates
Who cannot join
- Day 3 embryo transfer cycles
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sunrise fertility center
Cairo
Dr.Sherif Basha Sief, MD, 0020238517677, info@sunriseivf.net
About this study
Official title: The Blastocyst Development and Clinical Outcome in Single Step Medium With or Without Renewal on Day 3 in a Time-lapse Incubator
Culture media used to support development of zygotes to the blastocyst stage is based on two basic philosophies: a single step medium "let-the-embryo-choose" or a sequential medium "back-to-nature".
For single step media, there are two types of protocol can be used for the culture of human preimplantation embryos:
Read more
- Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo culture
- Uninterrupted single embryo culture, in which the same single medium is used throughout the 5-6 days of culture with no replenishment or replacement on Day 3.
Investigators aim to compare the blastocyst development and clinical outcome between the two types of protocols of a single medium (with or without renewal on Day 3)
- Conditions
- Sub-optimal Culture Conditions
- Being tested
- Culture media renwal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culture media renwalProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Uninterrupted single embryo culture | No intervention | The same single medium is used throughout the 5-6 days of culture with no replenishment on day 3. |
| Interrupted single medium culture | Experimental | The single step medium is renewed on Day 3 of embryo culture. Receives: Procedure: Culture media renwal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
diagnosed by the presence of a heartbeat in the gestational sac visualized by ultrasound
Measured: 4 weeks post embryo transfer
Secondary outcomes (2)
Implantation rate
the number of intrauterine gestational sacs over the total number of embryos transferred
Measured: 4-6 weeks post embryo transfer
Blastocyst formation rate
Measured: 5-6 days post intracytoplasmic sperm injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sub-optimal Culture ConditionsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar AlMaraa Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin, Dar AlMaraa Center
- Investigators
- Yasmin Magdi, M.Sc, Principal investigator, Dar Almaraa fertility and gynacology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778217
- Sponsor's protocol ID
- 006734
- Status last verified
- Jun 2016
- First submitted
- 17 May 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Costa-Borges N, Belles M, Meseguer M, Galliano D, Ballesteros A, Calderon G. Blastocyst development in single medium with or without renewal on day 3: a prospective cohort study on sibling donor oocytes in a time-lapse incubator. Fertil Steril. 2016 Mar;105(3):707-713. doi: 10.1016/j.fertnstert.2015.11.038. Epub 2015 Dec 12.
PubMed 26690010
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Blastocyst Development and Clinical Outcome in Single Step Medium With or Without Renewal on Day 3 in a Time-lapse Incubator
- ClinicalTrials.gov ID
- NCT02778217
- Acronym / sponsor ID
- 006734
- Conditions
- Sub-optimal Culture Conditions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dar AlMaraa CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 19 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.
Culture media used to support development of zygotes to the blastocyst stage is based on two basic philosophies: a single step medium "let-the-embryo-choose" or a sequential medium "back-to-nature".
For single step media, there are two types of protocol can be used for the culture of human preimplantation embryos:
- Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo culture
- Uninterrupted single embryo culture, in which the same single medium is used throughout the 5-6 days of culture with no replenishment or replacement on Day 3.
Investigators aim to compare the blastocyst development and clinical outcome between the two types of protocols of a single medium (with or without renewal on Day 3)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uninterrupted single embryo culture | No intervention | –The same single medium is used throughout the 5-6 days of culture with no replenishment on day 3. |
| Interrupted single medium culture | Experimental | Procedure: Culture media renwalThe single step medium is renewed on Day 3 of embryo culture. |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female partners were under the age of 39 years
- Intracytoplasmic sperm injection (ICSI) was performed using fresh ejaculates
Key exclusion criteria (1 listed)
- Day 3 embryo transfer cycles
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 |
|---|---|---|
| Culture media renwal | Procedure or surgery | Interrupted single medium culture |
Primary outcome
Clinical pregnancy rate
Time frame: 4 weeks post embryo transfer
diagnosed by the presence of a heartbeat in the gestational sac visualized by ultrasound
2 secondary outcomes
Implantation rate
Time frame: 4-6 weeks post embryo transfer
Blastocyst formation rate
Time frame: 5-6 days post intracytoplasmic sperm injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Results publication: PubMed 26690010Costa-Borges N, Belles M, Meseguer M, Galliano D, Ballesteros A, Calderon G. Blastocyst development in single medium with or without renewal on day 3: a prospective cohort study on sibling donor oocytes in a time-lapse incubator. Fertil Steril. 2016 Mar;105(3):707-713. doi: 10.1016/j.fertnstert.2015.11.038. Epub 2015 Dec 12.
- Individual participant dataSharing planned: Undecided
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.
Yasmin Magdi, M.Sc principal investigator
Dar Almaraa fertility and gynacology 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 Culture media renwal in people with Sub-optimal Culture Conditions, run by Dar AlMaraa 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 2 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: status not confirmed, as of the sponsor's last update on 14 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmin Magdi, M.Sc (+201282313979, Yas.magdi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 4 weeks post embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778217, which also lists 1 linked publication.
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 14 Jun 2016.