Pregnancy, OvarianNCT03463278
The Number of Blastocysts Formed in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate
An observational study of Pregnancy, Ovarian, run by Assisting Nature at 1 site in Greece.
Trial summary
A prospective study of the blastulation rate in the outcome of the Freeze all strategy Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Ovarian
- What is being tested?
- Pregnancy Rate
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2013to 31 Dec 2021
- 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 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged 20-39 years old following blastocyst culture after ICSI cycle in Freeze all Strategy
Who may be able to join
- primary infertility
- age 20-39 years;
- body mass index (BMI) 18-29kg/m2;
- regular menstrual cycle of 26-35days,
- presumed to be ovulatory;
- >1mil/ml spermatozoa;
- short antagonist protocol
Who cannot join
- poor responders;
- age ≥40;
- TESE sperm;
- PGS cycles;
- donor oocytes;
- donor sperm
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Assisting Nature
Thessaloniki, 57001
Evaggelos Papanikolaou, MD, PhD, 00302310424294, embryology@assistingnature.gr
Nikos Peitsidis, MD, MSc, 00306978410100, nickpeits@windowslive.com
About this study
Official title: The Impact of Blastulation Rate in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate
A prospective study of the blastulation rate in the outcome of the Freeze all strategy
Read the detailed description
A prospective study of the blastulation rate in women under the age of 40 years following Freeze all strategy, according to AMH levels and sperm parameters.
Study group 1: number of vitrified blastocysts 0-4 Study group 2: number of vitrified blastocysts 5-7 Study group 3: number of vitrified blastocysts >7
- Conditions
- Pregnancy, Ovarian
- Being tested
- Pregnancy Rate
- Keywords
- blastocyst, Freeze-all, IVF, Cumulative results, cumulative delivery rate
- Medical subject headings
- Pregnancy, Ovarian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy RateDiagnostic test
The pregnancy and live birth rate according to number of blastocysts formed in our three groups
| Study group | Role | What they receive |
|---|---|---|
| 0-4 blastocysts | group A: cumulative pregnancy rate of 0-4 blastocysts vitrified Receives: Diagnostic Test: Pregnancy Rate | |
| 5-7 blastocysts | group B: cumulative pregnancy rate of 5-7 blastocysts vitrified Receives: Diagnostic Test: Pregnancy Rate | |
| >7 blastocysts | group C: cumulative pregnancy rate of >7 blastocysts vitrified Receives: Diagnostic Test: Pregnancy Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Live Birth rate according to blastulation rate
Cumulative Live Birth rate according to blastulation rate
Measured: 5 days of embryo culture
Secondary outcomes (1)
Cumulative Pregnancy rate according to blastulation rate
Cumulative Pregnancy rate according to blastulation rate
Measured: 5 days of embryo culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start1 Nov 2013
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, OvarianStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assisting Nature
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evangelos Papanikolaou, MD, PhD, Principal investigator, Assisting Nature
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463278
- Sponsor's protocol ID
- Blastocyst-AN004
- Status last verified
- Oct 2020
- First submitted
- 2 Mar 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Blastulation Rate in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate
- ClinicalTrials.gov ID
- NCT03463278
- Acronym / sponsor ID
- Blastocyst-AN004
- Conditions
- Pregnancy, Ovarian
- Keywords
- blastocyst, Freeze-all, IVF, Cumulative results, cumulative delivery rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assisting NatureUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Mar 2018 (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 study of the blastulation rate in the outcome of the Freeze all strategy
Detailed description
A prospective study of the blastulation rate in women under the age of 40 years following Freeze all strategy, according to AMH levels and sperm parameters.
Study group 1: number of vitrified blastocysts 0-4 Study group 2: number of vitrified blastocysts 5-7 Study group 3: number of vitrified blastocysts >7
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0-4 blastocysts | – | Diagnostic Test: Pregnancy Rategroup A: cumulative pregnancy rate of 0-4 blastocysts vitrified |
| 5-7 blastocysts | – | Diagnostic Test: Pregnancy Rategroup B: cumulative pregnancy rate of 5-7 blastocysts vitrified |
| >7 blastocysts | – | Diagnostic Test: Pregnancy Rategroup C: cumulative pregnancy rate of >7 blastocysts vitrified |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 20-39 years old following blastocyst culture after ICSI cycle in Freeze all Strategy
Key inclusion criteria (7 listed)
- primary infertility
- age 20-39 years;
- body mass index (BMI) 18-29kg/m2;
- regular menstrual cycle of 26-35days,
- presumed to be ovulatory;
Key exclusion criteria (6 listed)
- poor responders;
- age ≥40;
- TESE sperm;
- PGS cycles;
- donor oocytes;
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 |
|---|---|---|
| Pregnancy RateThe pregnancy and live birth rate according to number of blastocysts formed in our three groups | Diagnostic test | 0-4 blastocysts, 5-7 blastocysts, >7 blastocysts |
Primary outcome
Cumulative Live Birth rate according to blastulation rate
Time frame: 5 days of embryo culture
Cumulative Live Birth rate according to blastulation rate
1 secondary outcome
Cumulative Pregnancy rate according to blastulation rate
Time frame: 5 days of embryo culture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Evangelos Papanikolaou, MD, PhD principal investigator
Assisting Nature
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Ovarian, run by Assisting Nature at 1 site in Greece.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Oct 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 Greece. 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 Tatiana Chartomatsidou, MSc (00302310424294, embryology@assistingnature.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Live Birth rate according to blastulation rate (time frame: 5 days of embryo culture). 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 8 Oct 2020.