NCT02575924

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

October 8, 2015

Last Update Submit

January 14, 2016

Conditions

Poor ResponderSevere Male InfertilityEmbryo DevelopmentBlastocystCulture Media

Keywords

mediablastocystmale infertilitypoor responderspgs

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • ploidy status

    six months

Study Arms (6)

sequential medium female age>=40

ACTIVE COMPARATOR

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

sequential medium female age<40

ACTIVE COMPARATOR

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

sequential medium sperm testis retrieval

ACTIVE COMPARATOR

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

one step medium female age>=40

ACTIVE COMPARATOR

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

one step medium female age<40

ACTIVE COMPARATOR

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

one step medium sperm testis retrieval

ACTIVE COMPARATOR

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

Interventions

sequential mediumDRUG

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

Also known as: Quinn's Advantage® Fertilization Medium, Quinn's Advantage® Cleavage Medium, Quinn's Advantage® Blastocyst Medium
sequential medium female age<40sequential medium female age>=40sequential medium sperm testis retrieval
1-step mediumDRUG

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

Also known as: SAGE 1-Step™ with Human Albumin Solution
one step medium female age<40one step medium female age>=40one step medium sperm testis retrieval

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • any other

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Reproductive Medicine

Rome, RM, 00149, Italy

RECRUITING

Related Publications (9)

  • 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.

    PMID: 23315059BACKGROUND

  • 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.

    PMID: 18847602BACKGROUND

  • 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.

    PMID: 25035437BACKGROUND

  • 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.

    PMID: 22714134BACKGROUND

  • 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.

    PMID: 16818962BACKGROUND

  • 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.

    PMID: 17090393BACKGROUND

  • 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.

    PMID: 23385469BACKGROUND

  • 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.

    PMID: 19523617BACKGROUND

  • 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.

    PMID: 23862646BACKGROUND

MeSH Terms

Conditions

Infertility, MaleMental Retardation, X-Linked 59

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • MariaGiulia Minasi, Biology

    European Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ermanno Greco, Medicine

CONTACT

0665975318grecoe@hotmail.it

MariaGiulia Minasi, Biology

CONTACT

0665975659mg.minasi@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 15, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

IT(1)