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Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal embryos before the transfer in IVF treatments in many cases. There is great debate in the scientific community as to whether this is an efficient practice in patients of different prognosis.
This prospective and randomized study seeks to study the results of chromosomal diagnosis using the new Comparative Genomic hybridization (CGH) arrays technique by practicing Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not on the other arm in order to compare the results. The investigators will study the ongoing pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male severe factor (≥2 million spermatozoids/ml.).
The randomized controlled trial results of advanced maternal age was completed and published (Rubio et al., Fertility&Sterility 2017).
The randomized controlled trial results of the male factor indication was terminated with anticipation due to the change of the technology that prevented recruitment of patients using the old technology (that one used in the study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B - Severe Male Factor | Experimental | PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst) |
|
| Group B - Advanced Age | Experimental | PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst) |
|
| Group A - Advanced Age | Active Comparator | Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group |
|
| Group A - Severe Male Factor | Active Comparator | Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PGS | Genetic | Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing Implantation and Pregnancy Rate | 9 months |
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Inclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:
Exclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Simon, MDPhD | Director | Principal Investigator |
| Carmen Rubio, PhD | Igenomix | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid | Valencia | 46015 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25599824 | Derived | Dahdouh EM, Balayla J, Garcia-Velasco JA. Impact of blastocyst biopsy and comprehensive chromosome screening technology on preimplantation genetic screening: a systematic review of randomized controlled trials. Reprod Biomed Online. 2015 Mar;30(3):281-9. doi: 10.1016/j.rbmo.2014.11.015. Epub 2014 Dec 11. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D000782 | Aneuploidy |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
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| PGS | Genetic | Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts. |
|
| Prolonged culture | Other | The embryos will be in prolonged culture and on going embryos transferred on Day 5 . |
|
| Prolonged culture | Other | Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |