Back to resultsPreimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor
Primary Purpose
Embryo Aneuploidies, Implantation Rates, Infertility
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PGS
PGS
Prolonged culture
Prolonged culture
Sponsored by
About this trial
This is an interventional prevention trial for Embryo Aneuploidies focused on measuring PGS, CGH, Aneuploidy, Advanced maternal age, Male factor
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.
Sites / Locations
- SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Group B - Severe Male Factor
Group B - Advanced Age
Group A - Advanced Age
Group A - Severe Male Factor
Arm Description
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group.
Outcomes
Primary Outcome Measures
Ongoing Implantation and Pregnancy Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01571076
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Igenomix
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embryo Aneuploidies, Implantation Rates, Infertility
Keywords
PGS, CGH, Aneuploidy, Advanced maternal age, Male factor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group B - Severe Male Factor
Arm Type
Experimental
Arm Description
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
Arm Title
Group B - Advanced Age
Arm Type
Experimental
Arm Description
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
Arm Title
Group A - Advanced Age
Arm Type
Active Comparator
Arm Description
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group
Arm Title
Group A - Severe Male Factor
Arm Type
Active Comparator
Arm Description
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group.
Intervention Type
Genetic
Intervention Name(s)
PGS
Intervention Description
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
Intervention Type
Genetic
Intervention Name(s)
PGS
Intervention Description
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
Intervention Type
Other
Intervention Name(s)
Prolonged culture
Intervention Description
The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
Intervention Type
Other
Intervention Name(s)
Prolonged culture
Intervention Description
Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.
Primary Outcome Measure Information:
Title
Ongoing Implantation and Pregnancy Rate
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Simon, MDPhD
Organizational Affiliation
Director
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmen Rubio, PhD
Organizational Affiliation
Igenomix
Official's Role
Study Chair
Facility Information:
Facility Name
SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid
City
Valencia
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25599824
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.
Results Reference
derived
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Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor
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