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

NCT ID: NCT02575924

Last Updated: 2016-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-12-31

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.

Conditions

Poor Responder; Severe Male Infertility; Embryo Development; Blastocyst; Culture Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

sequential medium

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

sequential medium

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

sequential medium

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

1-step medium

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

1-step medium

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

1-step medium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

1-step medium

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

Intervention Type: DRUG

Other Intervention Names

Quinn's Advantage® Fertilization Medium; Quinn's Advantage® Cleavage Medium; Quinn's Advantage® Blastocyst Medium; SAGE 1-Step™ with Human Albumin Solution

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• any other

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MariaGiulia Minasi, Biology

Role: PRINCIPAL_INVESTIGATOR

European Hospital

Locations

Center for Reproductive Medicine

Rome, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Ermanno Greco, Medicine

Role: CONTACT

grecoe@hotmail.it

0665975318

MariaGiulia Minasi, Biology

Role: CONTACT

mg.minasi@gmail.com

0665975659

Facility Contacts

Ermanno Greco, Medicine

Role: primary

grecoe@hotmail.it

+39-0665975318

Maria Giulia Minasi, Biology

Role: backup

mg.minasi@gmail.com

+39-0665975659

References

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.

Reference Type: BACKGROUND

PMID: 23315059 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18847602 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25035437 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22714134 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16818962 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17090393 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23385469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19523617 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23862646 (View on PubMed)

Other Identifiers

MGM13

Identifier Type: -

Identifier Source: org_study_id