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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02575924
Enrollment
24
Registered
2015-10-15
Start date
2015-06-30
Completion date
2017-12-31
Last updated
2016-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

media, blastocyst, male infertility, poor responders, pgs

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.

Interventions

DRUGsequential 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

DRUG1-step medium

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

Sponsors

European Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* any other

Design outcomes

Primary

MeasureTime frameDescription
blastocystis development ratesix months
implantation ratesix months
clinical pregnancy rateone yeartotal number of gestational chambers resulting from the total embryo transferred

Secondary

MeasureTime frameDescription
ploidy statussix monthsEmbryo genetic status after chromosomal screening

Countries

Italy

Contacts

Primary ContactErmanno Greco, Medicine
grecoe@hotmail.it0665975318
Backup ContactMariaGiulia Minasi, Biology
mg.minasi@gmail.com0665975659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026