Condition category
Pregnancy and Childbirth
Date applied
26/01/2018
Date assigned
01/02/2018
Last edited
01/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cryopreservation is the use of very low temperatures to preserve living cells and tissues. Sperm cryopreservation is an essential procedure of Assisted Reproduction Technologies (ART) to preserve male fertility and ensure that the specimen is available on the day of the egg retrieval regardless of the availability of the male partner. Currently, the most commonly used technique for sperm cryopreservation is slow freezing. Nevertheless, this technique has been shown to decrease sperm quality. During the last years, vitrification has been proposed as an alternative to conventional freezing. This technique is based on the ultra-rapid descent and rise of temperatures, avoiding ice crystal formation and its associated effects. Vitrification improves cell survival rates and reduces cell damage. This technique has been widely used for eggs and embryos but it has been hardly applied to human sperm. Recently, the development of EasySperm®, a new cryoprotectant-free vitrification method for human sperm, provided an improved and reliable alternative for sperm cryopreservation. This new method has been tested in normal sperm samples with better preservation of sperm quality compared to slow freezing. The aim of this study is to compare the effectiveness of the EasySperm® vitrification protocol with conventional slow freezing in ART cycles.

Who can participate?
Couples who are interested in ART with an egg donation program. The male patients should have normal sperm and be aged less than 45. The female patients should have no endometrial (womb lining) alterations and be aged less than 48.

What does the study involve?
Patients are randomly allocated to one of two groups: group 1: vitrification and group 2: slow freezing. In both groups sperm cryopreservation is performed using both the vitrification and slow freezing techniques. Half of the donated eggs are fertilised with vitrified/warmed sperm and the other half with frozen/thawed sperm. All embryos are grown to day 5 and single good quality embryos are transferred to the woman's womb. In group 1 the embryo is selected from the embryos produced by the vitrified/warmed sperm. In group 2 the embryo is selected from the embryos produced by the frozen/thawed sperm. Sperm fertilisation ability, embryo quality and developmental potential and clinical outcomes are assessed and compared between the groups.

What are the possible benefits and risks of participating?
The results will show which technique is the best to be used in daily practice. The cryopreservation protocol based on vitrification is expected to result in better embryo development and quality and improved clinical outcomes. There are no risks of participating.

Where is the study run from?
1. IVF Spain Alicante (Alicante, Spain)
2. IVF Donostia (San Sebastian, Spain)

When is the study starting and how long is it expected to run for?
May 2016 to August 2020

Who is funding the study?
IVF Spain Foundation (Spain)

Who is the main contact?
Ms Llanos Medrano López-Tello

Trial website

Contact information

Type

Scientific

Primary contact

Ms Llanos Medrano

ORCID ID

http://orcid.org/0000-0002-7053-7423

Contact details

Av. Ansaldo
Alicante
03540
Spain
+34 (0)965267890
mll.lopez@ivf-spain.com

Type

Scientific

Additional contact

Dr Maria Enciso

ORCID ID

http://orcid.org/0000-0002-3238-7065

Contact details

Carrer Britania
Alacant
03540
Spain
+34 (0)618 77 40 99
m.enciso@igls.net

Type

Scientific

Additional contact

Dr Yosu Franco

ORCID ID

Contact details

Begiristain Doktorea Pasealekua
Donostia
20014
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016ACE

Study information

Scientific title

Comparison of the efficacy of EasySperm® vitrification protocol vs conventional slow freezing in assisted reproduction treatments

Acronym

CEES

Study hypothesis

The cryopreservation protocol based on vitrification is expected to result in better embryo development and quality and improved clinical outcomes.

Ethics approval

Alacant General Hospital, 01/07/2016, ref: CEIC PI2016/18

Study design

Prospective randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: human fertility / Disease: No specific disease

Intervention

The method of randomisation: the history number of the patients is used for the randomisation: odd number goes to group 1, even number to group 2.

Group 1: Sperm cryopreservation will be performed using both vitrification and slow freezing techniques. Half of the donated oocytes will be fertilised with vitrified spermatozoa and the other half with frozen spermatozoa. The best single good morphological quality blastocyst (BB quality at least) among the embryos produced by vitrified/warmed spermatozoa will be selected and transferred.

Group 2: Sperm cryopreservation will be performed using both vitrification and slow freezing techniques. Half of the donated oocytes will be fertilised with vitrified spermatozoa and the other half with frozen spermatozoa. The best single good morphological quality blastocyst (BB quality at least) among the embryos produced by frozen/thawed spermatozoa will be selected and transferred.

Sperm fertilisation ability, embryo quality and developmental potential and clinical outcomes will be assessed and compared between the groups. The duration of follow-up is around 4 years.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Pregnancy rates, measured using the hormone β-HCG for the positive beta, echography for the presence of sac, cardiac activity, all measured at one time (10 days after embryo transfer for the beta, in the 4th or 5th week after embryo transfer and 7th-9th week after embryo transfer, respectively). The results of the birth are obtained 10 months after embryo transfer.

Secondary outcome measures

1. Sperm quality parameters (sperm count, motility, morphology, vitality, apoptosis and DNA integrity measured by flow cytometry), measured on the day of egg retrieval (post cryopreservation)
2. Sperm competence in terms of fertilization rate and blastocyst formation rate. The fertilization rate is the number of zygotes with good fertilization vs number of eggs, recorded the day after egg retrieval (day 1 of development). The blastocyst formation rate is the number of blastocyst vs zygotes, recorded on day 5 and 6 of development.
3. Embryo quality measured using Gardner’s cataloging (Gardner DK, Schoolcraft WB, 2008) and the kinetics of the embryos measured using an incubator with time-lapse technology. The embryo quality is assessed on day 5 and 6 (once a day) and the time-lapse data are collected on day 5 of development (once a day)
4. Chromosome status evaluated by PGD-A (Preimplantation Genetic Diagnosis for aneuploidy) and the results are obtained 20 days after egg retrieval

Overall trial start date

01/05/2016

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Couples who are interested in ART with an egg donation program
2. The male patients have to present a normozoospermic spermiogram and an age less than 45
3. The female patients have not to present endometrial alterations and an age less to 48

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100

Participant exclusion criteria

1. Couples who are interested in ART with own eggs
2. Male patients with not normozoospermic spermiogram and an age greater than 45
3. Female patients with endometrial alterations and more than 48 years old

Recruitment start date

13/07/2016

Recruitment end date

31/08/2019

Locations

Countries of recruitment

Spain

Trial participating centre

IVF Spain
Av. Ansaldo
Alicante
03540
Spain

Sponsor information

Organisation

iGLS

Sponsor details

Carrer Britania
Alicante
03540
Spain

Sponsor type

Other

Website

https://www.igls.net/es/

Funders

Funder type

Hospital/treatment centre

Funder name

IVF Spain Alicante

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Academic outputs will include a minimum of two papers submitted to high-impact peer reviewed journals, and at least three conference presentations or workshops.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Ms Llanos Medrano López-Tello.

Intention to publish date

30/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes