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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-02-28

Brief Summary

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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.).

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Detailed Description

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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).

Conditions

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Embryo Aneuploidies Implantation Rates Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group B - Severe Male Factor

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

Group Type EXPERIMENTAL

Prolonged culture

Intervention Type OTHER

Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.

Group B - Advanced Age

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

Group Type EXPERIMENTAL

Prolonged culture

Intervention Type OTHER

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

Group A - Advanced Age

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

Group Type ACTIVE_COMPARATOR

PGS

Intervention Type GENETIC

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

Group A - Severe Male Factor

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

Group Type ACTIVE_COMPARATOR

PGS

Intervention Type GENETIC

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

Interventions

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PGS

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

Intervention Type GENETIC

PGS

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

Intervention Type GENETIC

Prolonged culture

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

Intervention Type OTHER

Prolonged culture

Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes