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

Infertility Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571076
• Other study ID #: 1112-C-091-CR
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2019
• Source: Igenomix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneuploidy
• Embryo Aneuploidies
• Implantation Rates
• Infertility

Intervention

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

Other:
• Prolonged culture
The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
• Prolonged culture
Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.

Locations

Country	Name	City	State
Spain	SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Igenomix

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Implantation and Pregnancy Rate		9 months