Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor

Study Overview
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Brief Summary
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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.).

Detailed Description
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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).

Official Title
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Prospective and Randomized Study of the Use of Comparative Genomic Hybridization (CGH) Arrays to Study Embryo Aneuploidies in Female Advanced Age and Male Factor In Vitro Fertilization (IVF) Patients.

Conditions
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Embryo Aneuploidies, Implantation Rates, Infertility

Intervention / Treatment
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* Genetic: PGS
* Genetic: PGS
* Other: Prolonged culture
* Other: Prolonged culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR: Women's Age: 38- 41 years old (both included) Men's Age: 18-60 years old (both included) Ovulation triggered with human chorionic gonadotrophin (hCG) (Ovitrelle, Merck-Serono, Madrid) Number of Oocytes metaphase II (MII): ≥ 5 (fresh, not vitrified) Quality of semen: ≥ 5 millions spermatozoids/ml Exclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR: Number of Oocytes metaphase II (MII): <5 oocytes Number of Oocytes obtained: >20 Estradiol on the day of human chorionic gonadotrophin (hCG) >3000 pgr/ml administration. Progesterone on the day of hCG >1,5 pmol/l administration ≥ 2 previous miscarriages:biochemical,clinical,ectopic or a combination) Any un corrected alteration in a previous study. Other indications of (Preimplantation Genetic Diagnosis.Screening) PGD-S, such as monogenic illnesses, translocations, repeated implantation failure, repeated miscarriages, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B - Severe Male Factor<br>PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst) | Other: Prolonged culture<br>* Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.<br>|
| Experimental: Group B - Advanced Age<br>PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst) | Other: Prolonged culture<br>* The embryos will be in prolonged culture and on going embryos transferred on Day 5 .<br>|
| Active Comparator: Group A - Advanced Age<br>Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group | Genetic: PGS<br>* Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.<br>|
| Active Comparator: Group A - Severe Male Factor<br>Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group. | Genetic: PGS<br>* Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Implantation and Pregnancy Rate |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PGS, CGH, Aneuploidy, Advanced maternal age, Male factor