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

Primary Purpose

Poor Responder, Severe Male Infertility, Embryo Development

Status
Unknown status
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
sequential medium
1-step medium
Sponsored by
European Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Poor Responder focused on measuring media, blastocyst, male infertility, poor responders, pgs

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • advanced maternal age,
  • poor responder women (<=4 oocytes),
  • cryptozoospermia,
  • testicular retrieval of spermatozoa

Exclusion Criteria:

  • any other

Sites / Locations

  • Center for Reproductive MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

sequential medium female age>=40

sequential medium female age<40

sequential medium sperm testis retrieval

one step medium female age>=40

one step medium female age<40

one step medium sperm testis retrieval

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

blastocystis development rate
implantation rate
clinical pregnancy rate
total number of gestational chambers resulting from the total embryo transferred

Secondary Outcome Measures

ploidy status
Embryo genetic status after chromosomal screening

Full Information

First Posted
October 8, 2015
Last Updated
January 14, 2016
Sponsor
European Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02575924
Brief Title
Influence of Culture Media on Clinical Outcomes in Poor Responders or Severe Male Infertility
Official Title
Employing a Single Step Media Can Improve the Clinical Outcomes in Those Patient Who Usually Show an High Cycle Cancellation Rate?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Responder, Severe Male Infertility, Embryo Development, Blastocyst, Culture Media
Keywords
media, blastocyst, male infertility, poor responders, pgs

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sequential medium female age>=40
Arm Type
Active Comparator
Arm Description
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
Arm Title
sequential medium female age<40
Arm Type
Active Comparator
Arm Description
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
Arm Title
sequential medium sperm testis retrieval
Arm Type
Active Comparator
Arm Description
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
Arm Title
one step medium female age>=40
Arm Type
Active Comparator
Arm Description
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
Arm Title
one step medium female age<40
Arm Type
Active Comparator
Arm Description
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
Arm Title
one step medium sperm testis retrieval
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
sequential medium
Other Intervention Name(s)
Quinn's Advantage® Fertilization Medium, Quinn's Advantage® Cleavage Medium, Quinn's Advantage® Blastocyst Medium
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
1-step medium
Other Intervention Name(s)
SAGE 1-Step™ with Human Albumin Solution
Intervention Description
administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7
Primary Outcome Measure Information:
Title
blastocystis development rate
Time Frame
six months
Title
implantation rate
Time Frame
six months
Title
clinical pregnancy rate
Description
total number of gestational chambers resulting from the total embryo transferred
Time Frame
one year
Secondary Outcome Measure Information:
Title
ploidy status
Description
Embryo genetic status after chromosomal screening
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: advanced maternal age, poor responder women (<=4 oocytes), cryptozoospermia, testicular retrieval of spermatozoa Exclusion Criteria: any other
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ermanno Greco, Medicine
Phone
0665975318
Email
grecoe@hotmail.it
First Name & Middle Initial & Last Name or Official Title & Degree
MariaGiulia Minasi, Biology
Phone
0665975659
Email
mg.minasi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MariaGiulia Minasi, Biology
Organizational Affiliation
European Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Reproductive Medicine
City
Rome
State/Province
RM
ZIP/Postal Code
00149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ermanno Greco, Medicine
Phone
+39-0665975318
Email
grecoe@hotmail.it
First Name & Middle Initial & Last Name & Degree
Maria Giulia Minasi, Biology
Phone
+39-0665975659
Email
mg.minasi@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23315059
Citation
Basile N, Morbeck D, Garcia-Velasco J, Bronet F, Meseguer M. Type of culture media does not affect embryo kinetics: a time-lapse analysis of sibling oocytes. Hum Reprod. 2013 Mar;28(3):634-41. doi: 10.1093/humrep/des462. Epub 2013 Jan 12.
Results Reference
background
PubMed Identifier
18847602
Citation
Biggers JD, Summers MC. Choosing a culture medium: making informed choices. Fertil Steril. 2008 Sep;90(3):473-83. doi: 10.1016/j.fertnstert.2008.08.010.
Results Reference
background
PubMed Identifier
25035437
Citation
Chronopoulou E, Harper JC. IVF culture media: past, present and future. Hum Reprod Update. 2015 Jan-Feb;21(1):39-55. doi: 10.1093/humupd/dmu040. Epub 2014 Jul 17.
Results Reference
background
PubMed Identifier
22714134
Citation
Ciray HN, Aksoy T, Goktas C, Ozturk B, Bahceci M. Time-lapse evaluation of human embryo development in single versus sequential culture media--a sibling oocyte study. J Assist Reprod Genet. 2012 Sep;29(9):891-900. doi: 10.1007/s10815-012-9818-7. Epub 2012 Jun 20.
Results Reference
background
PubMed Identifier
16818962
Citation
Gardner DK, Lane M. One-step versus two-step culture of mouse preimplantation embryos. Hum Reprod. 2006 Jul;21(7):1935-6; author reply 1936-9. doi: 10.1093/humrep/del070. No abstract available.
Results Reference
background
PubMed Identifier
17090393
Citation
Lane M, Gardner DK. Embryo culture medium: which is the best? Best Pract Res Clin Obstet Gynaecol. 2007 Feb;21(1):83-100. doi: 10.1016/j.bpobgyn.2006.09.009. Epub 2006 Nov 7.
Results Reference
background
PubMed Identifier
23385469
Citation
Mantikou E, Youssef MA, van Wely M, van der Veen F, Al-Inany HG, Repping S, Mastenbroek S. Embryo culture media and IVF/ICSI success rates: a systematic review. Hum Reprod Update. 2013 May-Jun;19(3):210-20. doi: 10.1093/humupd/dms061. Epub 2013 Feb 5.
Results Reference
background
PubMed Identifier
19523617
Citation
Reed ML, Hamic A, Thompson DJ, Caperton CL. Continuous uninterrupted single medium culture without medium renewal versus sequential media culture: a sibling embryo study. Fertil Steril. 2009 Nov;92(5):1783-6. doi: 10.1016/j.fertnstert.2009.05.008. Epub 2009 Jun 12.
Results Reference
background
PubMed Identifier
23862646
Citation
Summers MC, Bird S, Mirzai FM, Thornhill A, Biggers JD. Human preimplantation embryo development in vitro: a morphological assessment of sibling zygotes cultured in a single medium or in sequential media. Hum Fertil (Camb). 2013 Dec;16(4):278-85. doi: 10.3109/14647273.2013.806823. Epub 2013 Jul 17.
Results Reference
background

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

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