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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01571076

Enrollment

240

Registered

2012-04-04

Start date

2012-02-29

Completion date

2015-02-28

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryo Aneuploidies, Implantation Rates, Infertility

Keywords

PGS, CGH, Aneuploidy, Advanced maternal age, Male factor

Brief summary

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

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).

Interventions

GENETICPGS

Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.

OTHERProlonged culture

The embryos will be in prolonged culture and on going embryos transferred on Day 5 .

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Ongoing Implantation and Pregnancy Rate	9 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026