Embryo CultureAGRUPADONCT01904006
Impact of Human Embryo Culture System on Live Birth
A study testing New Culture Condition and Standard Culture Condition in people with Embryo Culture, run by Vida Recoletas Sevilla at 1 site in Spain.
Trial summary
Previous studies in human and different mammals have proved that the embryo group culture (in the same culture medium drop) using a reduced volume is associated with a better embryo development. This is due to the effect of different autocrine and paracrine factors secreted by the embryos. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Embryo Culture
- What is being tested?
- New Culture Condition and Standard Culture Condition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jul 2013to Oct 2016
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- <38 years (with own oocytes) / <45 years (with oocyte donation).
- First treatment with own oocytes / any treatment with oocyte donation.
- ≥10 oocytes with a diameter of ≥10 mm.
Who cannot join
- Diseases that affect endometrial receptivity: endometriosis, hydrosalpinx, ovarian hyperstimulation syndrome, obesity, endocrinopathies, thrombophilia, congenital or acquired uterine anomalies.
- Patients under a treatment with genetic preimplantation diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement of Live Birth Rate With a New Standardized Human Embryo Culture System: a Prospective, Randomized, Controlled Trial
Previous studies in human and different mammals have proved that the embryo group culture (in the same culture medium drop) using a reduced volume is associated with a better embryo development. This is due to the effect of different autocrine and paracrine factors secreted by the embryos. Besides, previous studies with embryos from human and other mammals have shown that a high oxygen concentration may have a negative effect on embryo quality due to the generation of reactive oxygen species, which cause oxidative stress. The embryo culture at low oxygen tension is correlated to better success rates in IVF/ICSI treatments.
The purpose of this study is to evaluate the combined effect of the embryo group culture and the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments. The specific goal is to compare the embryo group culture in a reduced volume of medium at a low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®), whereas the second condition will be applied using a Heracell incubator (Heraeus®).
- Conditions
- Embryo Culture
- Being tested
- New Culture Condition, Standard Culture Condition
- Keywords
- grouped embryo culture, embryo density, low oxygen, benchtop incubator, culture condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Culture ConditionProcedure or surgery
Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.
Standard Culture ConditionProcedure or surgery
Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.
| Study group | Role | What they receive |
|---|---|---|
| New Culture Condition | Experimental | Intervention group embryos cultured grouped under low oxygen tension in benchtop incubators. Receives: Procedure: New Culture Condition |
| Standard Culture Condition | Active comparator | Control group embryos cultured individually under atmospheric oxygen tension in large-box incubators. Receives: Procedure: Standard Culture Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Confirmed when a gestational sac with heartbeat was observed in the uterus by ultrasound examination, performed 2-3 weeks after the positive result of the beta-hCG pregnancy test.
Measured: April 2013 - October 2016
Secondary outcomes (2)
Implantation rate
Number of embryos implanted per number of embryos transferred
Measured: April 2013 - October 2016
Live birth rate
Number of newborns per pregnancy achieved
Measured: April 2013 - October 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study start23 Jul 2013
- Primary completion17 Nov 2015
- Study completionOct 2016
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 Embryo CultureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myriam Ruiz, MSc, Study chair, Vida Recoletas SevillaVictor Blasco, MSc, Study chair, Vida Recoletas SevillaManuel Fernandez-Sánchez, PhD, Study director, Vida Recoletas Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904006
- Sponsor's protocol ID
- IVISEV-003AGR
- Acronym
- AGRUPADO
- Status last verified
- Apr 2018
- First submitted
- 17 Jul 2013
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruiz M, Santamaria-Lopez E, Blasco V, Hernaez MJ, Caligara C, Pellicer A, Fernandez-Sanchez M, Prados N. Effect of Group Embryo Culture under Low-Oxygen Tension in Benchtop Incubators on Human Embryo Culture: Prospective, Randomized, Controlled Trial. Reprod Sci. 2020 Jul;27(7):1522-1533. doi: 10.1007/s43032-020-00150-5. Epub 2020 Jan 28.
PubMed 31994003
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Live Birth Rate With a New Standardized Human Embryo Culture System: a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01904006
- Acronym / sponsor ID
- AGRUPADO / IVISEV-003AGR
- Conditions
- Embryo Culture
- Keywords
- grouped embryo culture, embryo density, low oxygen, benchtop incubator, culture condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- 23 Jul 2013 (actual)
- Primary completion
- 17 Nov 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Jul 2013 (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.
Previous studies in human and different mammals have proved that the embryo group culture (in the same culture medium drop) using a reduced volume is associated with a better embryo development. This is due to the effect of different autocrine and paracrine factors secreted by the embryos. Besides, previous studies with embryos from human and other mammals have shown that a high oxygen concentration may have a negative effect on embryo quality due to the generation of reactive oxygen species, which cause oxidative stress. The embryo culture at low oxygen tension is correlated to better success rates in IVF/ICSI treatments.
The purpose of this study is to evaluate the combined effect of the embryo group culture and the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments. The specific goal is to compare the embryo group culture in a reduced volume of medium at a low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®), whereas the second condition will be applied using a Heracell incubator (Heraeus®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Culture Condition | Experimental | Procedure: New Culture ConditionIntervention group embryos cultured grouped under low oxygen tension in benchtop incubators. |
| Standard Culture Condition | Active comparator | Procedure: Standard Culture ConditionControl group embryos cultured individually under atmospheric oxygen tension in large-box incubators. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- <38 years (with own oocytes) / <45 years (with oocyte donation).
- First treatment with own oocytes / any treatment with oocyte donation.
- ≥10 oocytes with a diameter of ≥10 mm.
Key exclusion criteria (2 listed)
- Diseases that affect endometrial receptivity: endometriosis, hydrosalpinx, ovarian hyperstimulation syndrome, obesity, endocrinopathies, thrombophilia, congenital or acquired uterine anomalies.
- Patients under a treatment with genetic preimplantation diagnosis.
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 |
|---|---|---|
| New Culture ConditionIntervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators. | Procedure or surgery | New Culture Condition |
| Standard Culture ConditionControl group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators. | Procedure or surgery | Standard Culture Condition |
Primary outcome
Clinical pregnancy rate
Time frame: April 2013 - October 2016
Confirmed when a gestational sac with heartbeat was observed in the uterus by ultrasound examination, performed 2-3 weeks after the positive result of the beta-hCG pregnancy test.
2 secondary outcomes
Implantation rate
Time frame: April 2013 - October 2016
Live birth rate
Time frame: April 2013 - October 2016
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 Apr 2018.
- Derived from this study: PubMed 31994003Ruiz M, Santamaria-Lopez E, Blasco V, Hernaez MJ, Caligara C, Pellicer A, Fernandez-Sanchez M, Prados N. Effect of Group Embryo Culture under Low-Oxygen Tension in Benchtop Incubators on Human Embryo Culture: Prospective, Randomized, Controlled Trial. Reprod Sci. 2020 Jul;27(7):1522-1533. doi: 10.1007/s43032-020-00150-5. Epub 2020 Jan 28.
- Individual participant dataSharing planned: No
Related trials for Embryo Culture
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RecruitingObservational study
Study of Abnormally Fertilized Embryos
Infertility (IVF Patients)
Recruiting
A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology
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OSC Co-culture for Rescue IVM of Human GV Oocytes
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Embryo Culture, Embryo Culture Media
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.
Myriam Ruiz, MSc study chair
Vida Recoletas Sevilla
Victor Blasco, MSc study chair
Vida Recoletas Sevilla
Manuel Fernandez-Sánchez, PhD study director
Vida Recoletas Sevilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Culture Condition and Standard Culture Condition in people with Embryo Culture, run by Vida Recoletas Sevilla at 1 site in Spain.
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 2 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 Apr 2018. 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 Spain. 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?
Clinical pregnancy rate (time frame: April 2013 - October 2016). 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 NCT01904006, 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 25 Apr 2018.