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

Igenomix

Status: Completed

Conditions: Infertility; Embryo Aneuploidies; Implantation Rates

Treatments: Other: Prolonged culture; Genetic: PGS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01571076

1112-C-091-CR

Details and patient eligibility

About

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.).

Full description

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).

Enrollment: 240 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

Group B - Severe Male Factor

Experimental group

Description:

PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)

Treatment:

Other: Prolonged culture

Other: Prolonged culture

Group B - Advanced Age

Experimental group

Description:

PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)

Treatment:

Other: Prolonged culture

Other: Prolonged culture

Group A - Advanced Age

Active Comparator group

Description:

Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group

Treatment:

Genetic: PGS

Genetic: PGS

Group A - Severe Male Factor

Active Comparator group

Description:

Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group.

Treatment:

Genetic: PGS

Genetic: PGS