International Pilot Study for Dual Non-invasive Assesment of Embryo Development
ConditionInfertility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-42
SponsorIgenomix
About this trial
Choosing the best embryo is one of the major challenges for achieving success in in vitro fertilization (IVF). Traditionally, embryo evaluation has been based on morphological quality (how the embryo looks like) and chromosomal status as diagnosed by a genetic testing. However, recently new techniques that do not require manipulation of the embryo have been developed and have shown promising results.
The goal of this observational study is, by combining two non-invasive techniques, to find out some parameters during embryo development which may be related with the embryo's chromosomic status. For that, infertile women planning to undergo an IVF/ICSI treatment with a recommended niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) will be invited to join the study. The main question it aims to answer is:
* Can morphokinetics parameters correlate with embryo chromosomal status?
Participants will follow their previously programmed IVF/ICSI treatment and no additional visits/interventions will be required by their participation in the study. The obtained embryos will be cultured in a time-lapse system instead of in a conventional incubator, and niPGT-A will be performed. Following the standard practice, a deferred single embryo transfer (SET) will be performed according to the niPGT-A results. After the transfer, patients will be followed-up as usual.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Study ICF signature.
Female age between 20 and 42 years (bot included).
IVF, ICSI or IVF/ICSI performed in fresh own or donated oocytes. Note: donor sperm is allowed.
niPGT-A cases with a deferred SET (of a day 6/7 vitrified blastocyst) for any medical indication.
Disqualifiers
Embryos with abnormal fertilization (different from 2PN). (Note: In case of no 2PN embryos, patients may repeat the COS cycle).
Female/couple with PGT-M and/or PGT-SR indication.
Assisted hatching and/or artificial collapse before media collection.
Known abnormal karyotype.
Trial population
Infertile women complying with the selection criteria who are patients at an assisted reproduction center and, by medical recommendation, are undergoing a fertility treatment with non-invasive preimplantational genetic testing for aneuploidies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
niPGT-A
Diagnostic testEmbryos will be cultured, from oocyte fertilization up to day 6/7 of development, in a time lapse system following the standard practice. On day 6/7, embryos will be vitrified and the embryos's media will be collected for niPGT-A analysis. Patients will undergo a single embryo transfer (SET) following the niPGT-A report indications. In the event of 1 or more embryos with the same niPGT-A score, the embryo for transfer will be determined by the site standard practice (morphology or time-lapse score). Patients who do not achieve a pregnancy after a niPGT-A guided SET can undergo as many niPGT-A guided SET or COS+niPGT-A cycles as they need to get pregnant, while the study recruitment phase is active.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Infertile women with medical recommendation of niPGT-A1 intervention
Trial outcomes
Primary outcomes
1
Identification of embryo morphokinetic parameters which correlate with niPGT-A results
Comparison of embryo morphokinetic parameters from the time-lapse (day 0 to day 6/7) with the niPGT-A results (informativity and ploidy)
Time frame
Up to 6/7 daysSecondary outcomes
1
Correlation between the implantation rate (IR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)
Analysis to determine the correlation between morphokinetic parameters and the IR, defined as the number of gestational sacs observed by vaginal ultrasound divided by the number of embryos transferred.
Time frame
Up to 4 weeks after the embryo transfer2
Correlation between the clinical pregnancy rate (CPR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)
Analysis to determine the correlation between morphokinetic parameters and the CPR, defined as the number of pregnancies with ultrasonographic visualization of one or more gestational sacs and/or fetal heartbeat, per embryo transfer.
Time frame
Up to 5-6 weeks after the embryo transfer3
Correlation between the biochemical pregnancy rate (BPR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)
Analysis to determine the correlation between morphokinetic parameters and the BPR, defined as the number of pregnancies diagnosed only by β-hCG detection (≥25 mIU/ml) without a gestational sac visualized by vaginal ultrasound, per number of pregnancies.
Time frame
Around 2 weeks after the embryo transfer4
Correlation between the ectopic pregnancy rate (EPR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET)
Analysis to determine the correlation between morphokinetic parameters and EPR, defined as the number of pregnancies outside the uterine cavity, diagnosed clinically, hormonally, by ultrasound, surgical visualization or histopathology, per number of pregnancies.
Time frame
Up to 4-5 weeks after the embryo transferOther outcomes
1
To evaluate the relathionship of the cell-free DNA (cfDNA) concentration of the spent blastocyst media (SBM) with morphokinetic parameters and/or niPGT-A
To assess the cfDNA concentration in a 20% of the SBMs and evaluate its correlation with morphokinetic parameters and/or niPGT-A
Time frame
Up to 6/7 days of embryo development Source ClinicalTrials.gov