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

January 14, 2016 updated by: European Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00149
        • Recruiting
        • Center for Reproductive Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • any other

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sequential medium female age>=40

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
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
Other Names:
  • Quinn's Advantage® Fertilization Medium
  • Quinn's Advantage® Cleavage Medium
  • Quinn's Advantage® Blastocyst Medium
Active Comparator: sequential medium female age<40

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
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
Other Names:
  • Quinn's Advantage® Fertilization Medium
  • Quinn's Advantage® Cleavage Medium
  • Quinn's Advantage® Blastocyst Medium
Active Comparator: sequential medium sperm testis retrieval

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
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
Other Names:
  • Quinn's Advantage® Fertilization Medium
  • Quinn's Advantage® Cleavage Medium
  • Quinn's Advantage® Blastocyst Medium
Active Comparator: one step medium female age>=40

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
administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7
Other Names:
  • SAGE 1-Step™ with Human Albumin Solution
Active Comparator: one step medium female age<40

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
administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7
Other Names:
  • SAGE 1-Step™ with Human Albumin Solution
Active Comparator: one step medium sperm testis retrieval

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
administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7
Other Names:
  • SAGE 1-Step™ with Human Albumin Solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Hospital

Investigators

  • Principal Investigator: MariaGiulia Minasi, Biology, European Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 12, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGM13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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