Clinical trial NCT01571076: Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Aneuploidies
Implantation Rates
Infertility
Keywords: PGS
CGH
Aneuploidy
Advanced maternal age
Male factor
Lead sponsor: Igenomix
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: Ongoing Implantation and Pregnancy Rate
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid
Study officials:
affiliation: Director
name: Carlos Simon, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Igenomix
name: Carmen Rubio, PhD
role: STUDY_CHAIR
References:
citation: Dahdouh EM, Balayla J, Garcia-Velasco JA. Impact of blastocyst biopsy and comprehensive chromosome screening technology on preimplantation genetic screening: a systematic review of randomized controlled trials. Reprod Biomed Online. 2015 Mar;30(3):281-9. doi: 10.1016/j.rbmo.2014.11.015. Epub 2014 Dec 11.