InfertilityNCT02189369
Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer
A study testing Day 3 embryo transfer and Day 5 embryo transfer in people with Infertility, run by Igenomix at 2 sites in Spain.
Trial summary
This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Day 3 embryo transfer and Day 5 embryo transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2015to Dec 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Any IVF patient being treated for single or double embryo transfer
- BMI: 20 - 30
- Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral Follicle Count)
- Elective embryo transfer
- Normal uterine cavity
- Age: ≤ 38 years old for patients with own oocytes; ≤ 50 years old for patients with donated oocytes.
Who cannot join
- Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
- Patients with severe male factor ( ≥ 2*106 espermatozoides/ml).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Fundación IVI
Valencia, Valencia, 46015
Carlos Gómez, Ma, +34670506469, carlos.gomez@igenomix.com
Carlos Simón, MD, PhD
- Recruiting
IVI Valencia
Valencia, Valencia, 46015
Carlos Gómez, MA, carlos.gomez@igenomix.com
Carlos Simón, MD, PhD
About this study
Official title: Clinical Validation of a Diagnostic Test Which Measures the Endometrial Prostaglandins Liquid 24 Hours Before Embryo Transfer and That is Capable of Predicting a State of Endometrial Receptivity
This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. This test is capable of predicting endometrial receptivity without the need of performing a biopsy.
- Conditions
- Infertility
- Being tested
- Day 3 embryo transfer, Day 5 embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day 3 embryo transferOther
Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
Day 5 embryo transferOther
Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Day 3 embryo-Own-above cutoff | Experimental | Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates Receives: Other: Day 3 embryo transfer |
| Day 5 embryo-Own-above cutoff | Experimental | Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates Receives: Other: Day 5 embryo transfer |
| Day 3 embryo-Donor-above cutoff | Experimental | Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates Receives: Other: Day 3 embryo transfer |
| Day 5 embryo-Donor- above cutoff | Experimental | Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates Receives: Other: Day 5 embryo transfer |
| Day 3 embryo-Donor-lower cutoff | Experimental | Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates Receives: Other: Day 3 embryo transfer |
| Day 5 embryo-Donor-lower cutoff | Experimental | Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates Receives: Other: Day 5 embryo transfer |
| Day 3 embryo-own-lower cutoff | Experimental | Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates Receives: Other: Day 3 embryo transfer |
| Day 5 embryo-own-lower cutoff | Experimental | Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates Receives: Other: Day 5 embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial receptivity
The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.
Measured: 24 hours before embryo transfer
Secondary outcomes (2)
Implantation rate
We will reffer a correlation between the prostaglandin results and the implantation rate.
Measured: 15 days
Pregnancy rate
We will reffer a correlation between the prostaglandin results and the implantation rate.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startFeb 2015
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Carlos Simon, Igenomix
- Investigators
- Carlos Simon, MD PhD, Principal investigator, Fundación IVI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189369
- Sponsor's protocol ID
- 1311-FIVI-135-CS
- Status last verified
- Mar 2017
- First submitted
- 10 Jul 2014
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Diagnostic Test Which Measures the Endometrial Prostaglandins Liquid 24 Hours Before Embryo Transfer and That is Capable of Predicting a State of Endometrial Receptivity
- ClinicalTrials.gov ID
- NCT02189369
- Acronym / sponsor ID
- 1311-FIVI-135-CS
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jul 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.
This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. This test is capable of predicting endometrial receptivity without the need of performing a biopsy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Day 3 embryo-Own-above cutoff | Experimental | Other: Day 3 embryo transferDay 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates |
| Day 5 embryo-Own-above cutoff | Experimental | Other: Day 5 embryo transferDay 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates |
| Day 3 embryo-Donor-above cutoff | Experimental | Other: Day 3 embryo transferDay 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates |
| Day 5 embryo-Donor- above cutoff | Experimental | Other: Day 5 embryo transferDay 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates |
| Day 3 embryo-Donor-lower cutoff | Experimental | Other: Day 3 embryo transferDay 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates |
| Day 5 embryo-Donor-lower cutoff | Experimental | Other: Day 5 embryo transferDay 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates |
| Day 3 embryo-own-lower cutoff | Experimental | Other: Day 3 embryo transferDay 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates |
| Day 5 embryo-own-lower cutoff | Experimental | Other: Day 5 embryo transferDay 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Any IVF patient being treated for single or double embryo transfer
- BMI: 20 - 30
- Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral Follicle Count)
- Elective embryo transfer
- Normal uterine cavity
Key exclusion criteria (2 listed)
- Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
- Patients with severe male factor ( ≥ 2*106 espermatozoides/ml).
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 |
|---|---|---|
| Day 3 embryo transferExtraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer | Other | Day 3 embryo-Donor-above cutoff, Day 3 embryo-Donor-lower cutoff, Day 3 embryo-Own-above cutoff, Day 3 embryo-own-lower cutoff |
| Day 5 embryo transferExtraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer | Other | Day 5 embryo-Donor- above cutoff, Day 5 embryo-Donor-lower cutoff, Day 5 embryo-Own-above cutoff, Day 5 embryo-own-lower cutoff |
Primary outcome
endometrial receptivity
Time frame: 24 hours before embryo transfer
The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.
2 secondary outcomes
Implantation rate
Time frame: 15 days
Pregnancy rate
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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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.
Carlos Simon, MD PhD principal investigator
Fundación IVI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day 3 embryo transfer and Day 5 embryo transfer in people with Infertility, run by Igenomix at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Gómez, MA (+34670506469, carlos.gomez@igenomix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial receptivity (time frame: 24 hours before 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 7 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.