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

Not Applicable

Completed

• Conditions: Embryo Aneuploidies; Implantation Rates; Infertility
• Interventions: Other: Prolonged culture; Genetic: PGS

• Registration Number: NCT01571076
• Lead Sponsor: Igenomix

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).

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Primary Completion: 2014-09
• Study Completion: 2015-02
• Status Verified: 2019-04
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B - Severe Male Factor	Prolonged culture	PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
Group A - Advanced Age	PGS	Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group
Group A - Severe Male Factor	PGS	Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group.
Group B - Advanced Age	Prolonged culture	PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)

Primary Outcome Measures

Name	Time	Method
Ongoing Implantation and Pregnancy Rate	9 months

Trial Locations

Locations (1)

SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid; 🇪🇸 Valencia, Spain