International Pilot Study for Dual Non-invasive Assesment of Embryo Development
NCT Number: NCT06524648
Acronym: PANDORA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infertility
Interventions: DIAGNOSTIC_TEST: niPGT-A
Sponsor: Igenomix
Sex: FEMALE
Age: ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2027-01
Locations: Kinderwunsch Institut Schenk, Dobl, A-8143, Austria|Fertty, Barcelona, 08010, Spain|Hospital Ruber Internacional, Madrid, 28034, Spain|Next Fertility Murcia, Murcia, 30007, Spain|Next Fertility Sevilla, Sevilla, 41012, Spain|Vida Recoletas Sevilla, Sevilla, 41092, Spain|Next Fertility Valencia, Valencia, 46009, Spain|Orchid IVF Clinic, Dubai, United Arab Emirates

Summary:
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.

Primary Outcome Measures: 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), Up to 6/7 days
Secondary Outcome Measures: 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., Up to 4 weeks after the embryo transfer|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., Up to 5-6 weeks after the embryo transfer|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., Around 2 weeks after the embryo transfer|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., Up to 4-5 weeks after the embryo transfer|Correlation between the clinical miscarriage rate (CMR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET), Analysis to determine the correlation between morphokinetic parameters and the CMR, defined as the number of spontaneous pregnancy losses before the 12th gestational week, in which a gestational sac/s was previously observed and heartbeat detected, per number of pregnancies., Over 12 gestational weeks|Correlation between the ongoing pregnancy rate (OPR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET), Analysis to determine the correlation between morphokinetic parameters and the OPR, defined as the number of pregnancies of, at least,12 gestational weeks (at least one fetus with a discernible heartbeat diagnosed) achieved per each embryo transfer., ≥12 gestational weeks|Correlation between the Live Birth Rate (LBR) and embryo morphokinetic parameters in the niPGT-A guided single embryo transfer (SET), Analysis to determine the correlation between morphokinetic parameters and the LBR, defined as the number of live births per embryo transfer. Live birth is defined as the complete expulsion or extraction from a woman of a product of conception after 22 weeks of gestation, which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached., 40 gestational weeks|Identification of morphokinetic parameters which might predict the optimal time for media collection., Comparison of niPGT-A informativity results with morphokinetic parameters, Up to 6/7 days of embryo development|To explore the relationship between niPGT-A results and morphokinetics with the type of ovarian stimulation and induction, the patient's intertility history and embryo quality, Multivariant analysis to determine how the relationship between niPGT-A results and morphokinetics is affected by ART/patient variables: type of ovarian stimulation and induction, the patient's intertility history (previous miscarriages, known infertility causes, previous implantation failures), and embryo quality (determined by standard morphology evaluation)., Over 3-4 weeks|Identification of the correlation between morphokinetic parameters and spent blastocyst media contamination, Correlate morphokinetic parameters with the presence of maternal and/or external DNA in the culture media for niPGT-A, Up to 6/7 days of embryo development|Comparison of the products of conception (POC) results with the niPGT-A results, Correlate the niPGT-A results with the POC results, Up to 12 gestational weeks|To study the relathionship among the morphokinetics, niPGT-A and the patient's body mass index (BMI), To anlyse the patient's BMI influence on the correlation between morphokinetics and niPGT-A, only when own oocytes are used., Up to 6/7 days
Other Outcome Measures: 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, Up to 6/7 days of embryo development