Influence of Culture Media on Clinical Outcomes in Poor Responders or Severe Male Infertility

Study Overview
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Brief Summary
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In this study the suitability of two -sequential and single step- commercially available culture media from the same brand was compared. The aim of such study is to verify whether is possible to improve the efficiency of infertility treatments in those couples who usually have a high cycle cancellation rate, such as poor responder patients and severe male infertility. The study population is composed of couples attending the fertility clinic: to this purpose all those couples approaching IVF treatments with a diagnosis of OAT, cryptozoospermia, advanced maternal age and women with a poor responder diagnosis were recruited. IVF treatments were randomly set to be cultured either with two-step sequential media or with one-step media to acquire data concerning the ongoing embryo culture development and clinical outcomes.

Detailed Description
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The final goal in the field of Assisted Reproductive Technology is to obtain a single healthy newborn. For that purpose, a lot of factors are strictly interconnected each other's and have to be carefully evaluated. The choice of embryo culture system and of embryo selection strategy plays a crucial role in obtain and identify the embryo with the highest implantation potential. One really important key factor is the choice of the culture media. Currently, there are numerous commercially available culture media showing very different compositions. Essentially two strategies have been applied for the design of culture media: 1) Back to nature for sequential media, based on the physiology of the embryo and the measured concentration of substances present in its natural environment and 2) Let the embryo choose for single step media, where none a priori assumption of the concentration of a component is made. In the literature, there are a lot of studies analyzing the effect of culture media on human preimplantation embryos development and comparing biological and clinical outcomes among different media compositions. Several studies performed a comparison about the development of human zygotes in either a one-step or two-step culture system. Usually there were no significant differences between the two culture media systems regarding biological or clinical outcomes. Anyway, a greater number of blastocysts were generally obtained by the continuous single medium culture if compared with sequential culture media, even if the implantation and clinical pregnancy rates are comparable.

Official Title
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Employing a Single Step Media Can Improve the Clinical Outcomes in Those Patient Who Usually Show an High Cycle Cancellation Rate?

Conditions
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Poor Responder, Severe Male Infertility, Embryo Development, Blastocyst, Culture Media

Intervention / Treatment
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* Drug: sequential medium
* Drug: 1-step medium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: advanced maternal age, poor responder women (<=4 oocytes), cryptozoospermia, testicular retrieval of spermatozoa Exclusion Criteria: any other

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sequential medium female age>=40<br>day 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3 day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5 day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 | Drug: sequential medium<br>* administration of Quinn's Advantage® Fertilization Medium on day0 administration of Quinn's Advantage® Cleavage Medium from day0 to day3 administration of Quinn's Advantage® Blastocyst Medium from day3 to day7<br>* Other names: Quinn's Advantage® Blastocyst Medium;|
| Active Comparator: sequential medium female age<40<br>day 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3 day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5 day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 | Drug: sequential medium<br>* administration of Quinn's Advantage® Fertilization Medium on day0 administration of Quinn's Advantage® Cleavage Medium from day0 to day3 administration of Quinn's Advantage® Blastocyst Medium from day3 to day7<br>* Other names: Quinn's Advantage® Blastocyst Medium;|
| Active Comparator: sequential medium sperm testis retrieval<br>day 0: suitable number of test tubes, each one filled with 1ml of SAGE-FERT medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE-CLEAVAGE medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day3 day3: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices and newer volumes of mineral oil to cover up the droplets till day5 day5: fitting volumes of SAGE-BLASTOCYSTS medium to replace all the culture devices without any mineral oil replacement till day7 | Drug: sequential medium<br>* administration of Quinn's Advantage® Fertilization Medium on day0 administration of Quinn's Advantage® Cleavage Medium from day0 to day3 administration of Quinn's Advantage® Blastocyst Medium from day3 to day7<br>* Other names: Quinn's Advantage® Blastocyst Medium;|
| Active Comparator: one step medium female age>=40<br>day 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 | Drug: 1-step medium<br>* administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7<br>* Other names: SAGE 1-Step™ with Human Albumin Solution;|
| Active Comparator: one step medium female age<40<br>day 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 | Drug: 1-step medium<br>* administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7<br>* Other names: SAGE 1-Step™ with Human Albumin Solution;|
| Active Comparator: one step medium sperm testis retrieval<br>day 0: suitable number of test tubes, each one filled with 1ml of SAGE 1-STEP medium to gather all the oocytes retrieved during the pick up (at most 3 oocytes/test tube) 1 or more culture dish with 6 droplets (35µl) of SAGE 1-STEP medium covered with mineral oil to culture the zygotes/embryos after ICSI procedure till day7 | Drug: 1-step medium<br>* administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7<br>* Other names: SAGE 1-Step™ with Human Albumin Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blastocystis development rate |  | six months | 
| implantation rate |  | six months | 
| clinical pregnancy rate | total number of gestational chambers resulting from the total embryo transferred | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ploidy status | Embryo genetic status after chromosomal screening | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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media, blastocyst, male infertility, poor responders, pgs