RBR-4k5mtn Human semen freezing : Effects of adding lipids and antioxidants in the quality of sperm

Date of registration: 10/17/2016 ^(mm/dd/yyyy)
Last approval date : 10/17/2016 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1173-4903

• Public title:

  en

  Human semen freezing : Effects of adding lipids and antioxidants in the quality of sperm

  pt-br

  Congelamento de sêmen humano: efeitos da adição de lipídios e antioxidantes na qualidade dos espermatozoides

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 35850214.4.0000.5440
    Issuing authority: Plataforma Brasil/Sistema Nacional de Ética em Pesquisa
  • 1.153.690
    Issuing authority: Comitê de Ética em Pesquisa do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Sponsors

• Primary sponsor: Faculdade de Medicina de Ribeirão Preto
• Secondary sponsor:
  • Institution: Invitra
• Supporting source:
  • Institution: Fundação de Ampara a Pesquisa do Estado de São Paulo

Health conditions

• Health conditions:

  en

  Infertility

  pt-br

  Infertilidade

• General descriptors for health conditions:

  en

  C12 Male urogenital diseases

  pt-br

  C12 Doenças urogenitais masculinas

  es

  C12 Enfermedades urogenitales masculinas

• Specific descriptors:

Interventions

• Interventions:

  en

  Intervention group: 63 men with normal semen parameters, evaluated by a sperm. The semen will be divided into two equal volumes, in which half will be frozen with the medium cryoprotectants currently used and the other half with cryoprotectants tested in the project. After a time the semen is thawed, re-analyzed by a semen analysis and compared the results to evaluate the freezing media. Control group: the frozen semen with the environment cryoprotectants currently used will control for frozen semen with the environment cryoprotectants tested in the project.

  pt-br

  Grupo intervenção: 63 homens com parâmetro seminal normal, avaliados através de um espermograma. O sêmen será dividido em dois volumes iguais, no qual metade será congelada com o meio crioprotetor usado atualmente e a outra com o meio crioprotetor testado no projeto. Passado algum tempo, o sêmen será descongelado, analisado novamente através de um espermograma e comparado os resultados para avaliar os meios de congelamento. Grupo controle: o sêmen congelado com o meio crioprotetor usado atualmente será controle para o sêmen congelado com o meio crioprotetor testado no projeto.

• Descriptors:

  en

  E01.370.225.500.620.760.160 Cryopreservation

  pt-br

  E01.370.225.500.620.760.160 Criopreservação

  es

  E01.370.225.500.620.760.160 Criopreservación

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 07/20/2015 ^(mm/dd/yyyy)
• Date last enrollment: 11/30/2016 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  63	M	18 Y	40 Y

• Inclusion criteria:

  en

  Men aged 18-40 years; able to collect the semen by masturbation ; are prior to sexual abstinence of at least two days

  pt-br

  Homens com idade entre 18 a 40 anos; consigam realizar a coleta de sêmen por masturbação; estejam com abstinência sexual prévia de pelo menos dois dias

• Exclusion criteria:

  en

  Semen volume smaller than 1.5 ml; concentration less than 15 million sperm / mL ; motility less than 32 %

  pt-br

  Volume de sêmen menor que 1,5 mL; concentração de espermatozoides menor que 15 milhões/mL; motilidade progressiva menor que 32 %

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Other	Parallel	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  The frozen semen with the environment cryoprotectants tested in the project has a higher number of spermatozoa with progressive motility, verified by the sperm.

  pt-br

  O sêmen congelado com o meio crioprotetor testado no projeto apresenta maior número de espermatozoides com motilidade progressiva, verificado por meio do espermograma.

  en

  The frozen semen with the environment cryoprotectants tested in the project presents fewer sperm with fragmented DNA, verified by the TUNEL test.

  pt-br

  O sêmen congelado com o meio crioprotetor testado no projeto apresenta menor número de espermatozoides com DNA fragmentado, verificado por meio do teste de TUNEL.

• Secondary outcomes:

  en

  The membrane of the sperm frozen with cryoprotectants tested through the project has adhered lipids that come from the environment, checked by scanning electron microscopy.

  pt-br

  A membrana dos espermatozoides congelados com o meio crioprotetor testado no projeto apresenta lipídios aderidos que são provenientes do meio, verificado por meio da microscopia eletrônica de varredura.

Contacts

• Public contact
  • Full name: Rosana Maria dos Reis
  • • Address: Av. Bandeirantes, 3900 - Monte Alegre
    • City: Ribeirão Preto / Brazil
    • Zip code: 14049-900
  • Phone: + 55 (16) 99992 5722
  • Email: romareis@fmrp.usp.br
  • Affiliation: Faculdade de Medicina de Ribeirão Preto
   
• Scientific contact
  • Full name: Aline Bomfim Silva
  • • Address: Av. Bandeirantes, 3900 - Monte Alegre
    • City: Ribeirão Preto / Brazil
    • Zip code: 14049-900
  • Phone: + 55 (16) 98120 7259
  • Email: alinebs@msn.com
  • Affiliation: Faculdade de Medicina de Ribeirão Preto
   
• Site contact
  • Full name: Fernanda Sicchieri
  • • Address: Av. Bandeirantes, 3900 - Monte Alegre
    • City: Ribeirão Preto / Brazil
    • Zip code: 14049-900
  • Phone: + 55 (16) 99156 6961
  • Email: fesicchieri@hotmail.com
  • Affiliation: Faculdade de Medicina de Ribeirão Preto
   

Additional links:

• Download in ICTRP format