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This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.
This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6). Patients are allocated through computer-generated randomization into one of the three groups: Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer (pET) after identification of the personalized window of implantation using the endometrial receptivity analysis (ERA) test, all of them following the usual clinical practice in a same-cycle embryo transfer.
A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with elective blastocyst transfer are randomized in this prospective, multicenter, open label and controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized embryo transfer (pET) | Experimental | Patients will undergo a cycle of endometrial preparation following hormone replacement therapy (HRT) and an endometrial biopsy in a substituted cycle after 5 days (around 120 hours) of progesterone administration. The ERA test will determine the window of implantation (WOI) for each patient and will recommend the best time for embryo transfer thereby increasing the chances of a successful outcome. In some specific cases (≤ 10%) a second biopsy will be required to help the bioinformatic predictor to ensure the most appropriated moment for the embryo transfer. In a different cycle, patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI and vitrified. In a subsequent cycle, following the ERA result, a personalized embryo transfer (pET) will be carried out following the same conditions in which the ERA test was obtained, using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage) |
|
| Frozen embryo transfer (FET) | Active Comparator | Patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In a subsequent cycle, following hormone replacement therapy (HRT), a frozen embryo transfer (FET) will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage). |
|
| Fresh embryo transfer (ET) | Active Comparator | Patients will undergo a controlled ovarian stimulation cycle (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In the same cycle, a fresh embryo transfer will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| personalized Embryo Transfer (pET) | Other |
| ||
| Frozen Embryo Transfer (FET) |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth delivery rate | Percentage of deliveries that resulted in at least one live birth per embryo transfer. | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation rate | The percentage of gestational sacs observed divided by the number of embryos transferred | 12 weeks |
| Pregnancy rate | The percentage of positive pregnancy test divided by the number of embryo transfers |
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Inclusion Criteria:
Exclusion Criteria:
Post-Randomization Exclusion Criteria:
Note: PGT-A is not an inclusion criteria neither an exclusion criteria, therefore those cycles in which PGT-A was performed will be included
Women undergoing IVF treatment
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Simon, MDPhD | IVI Valencia / Igenomix | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Reproductive Medicine UZ Brussles | Brussels | 1090 | Belgium | |||
| Centro de Infertilidade e Medicina Fetal do Norte Fluminence |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27365540 | Derived | Katzorke N, Vilella F, Ruiz M, Krussel JS, Simon C. Diagnosis of Endometrial-Factor Infertility: Current Approaches and New Avenues for Research. Geburtshilfe Frauenheilkd. 2016 Jun;76(6):699-703. doi: 10.1055/s-0042-103752. |
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| Other |
|
| Fresh Embryo Transfer (ET) | Other |
|
| 20 weeks |
| Biochemical pregnancies | A pregnancy diagnosed only by the detection of beta hCG in serum | 20 weeks |
| Ectopic pregnancies | A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology | 20 weeks |
| Clinical miscarriages | Spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age | 20 weeks |
| Cumulative pregnancy rate | Cumulative pregnancy rate in the 12 months after the first study embryo transfer | 12 months |
| Cumulative implantation rate | Cumulative implantation rate in the 12 months after the first study embryo transfer | 12 months |
| Cumulative live birth delivery rate | Cumulative live birth delivery rate per embryo transfer in the 12 months after the first study embryo transfer | 12 months |
| Campos dos Goytacazes |
| Rio de Janeiro |
| 28035-210 |
| Brazil |
| Centro de Reproduçao Humana Nilo Frantz | Porto Alegre | Rio Grande do Sul | Brazil |
| Centro de Reprodução Governador Mario Covas | São Paulo | Brazil |
| Sofia Hospital of Reproductive Medicine - SBALAGRM | Sofia | 1000 | Bulgaria |
| Oak Clinic Sumiyoshi | Osaka | 557-0045 | Japan |
| IVI Panama | Panama City | 0819 | Panama |
| IVI Bilbao | Leioa | Bizkaia | 48940 | Spain |
| IVI Madrid | Aravaca | Madrid | 24527 | Spain |
| IVI Vigo | Vigo | Pontevedra | 36203 | Spain |
| IVI Alicante | Alicante | 03015 | Spain |
| IVI Barcelona | Barcelona | 08017 | Spain |
| ProcreaTec | Madrid | 28036 | Spain |
| IVI Sevilla | Seville | 41011 | Spain |
| IVI Valencia | Valencia | 46015 | Spain |
| Bahceci Health Group | Istanbul | 34500 | Turkey (Türkiye) |