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Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination

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ClinicalTrials.gov Identifier: NCT02704936
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Basque Country University
Information provided by (Responsible Party):
IVI Bilbao

Brief Summary:
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI)

Condition or disease
Primary Infertility

Detailed Description:

Analyze lipid profiles in samples of sperm and seminal plasma of three populations:

  1. male sperm donors
  2. men assigned to a program of assisted reproduction with normal sperm / slightly abnormal successfully in the IUI;
  3. attached to a program of assisted reproduction with male semen Normal / slightly abnormal unsuccessfully in IUI

Establish partnerships between the composition of fatty acids, especially fatty acids polyunsaturated (PUFA) of the omega-3 (w3) series of samples analyzed parameterssemen and results of the IA to identify biochemical markers of fertility.

Assess markers found by checking the increase in the rate of success in the IA.


Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination
Study Start Date : December 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort
Male donor
42 samples of semen from male donor attached to a donation program Normal sperm count as WHO 2010.
IUI positive pregnancy
42 samples of semen from a program attached to patients for insemination Male indication Normal / slightly abnormal sperm count or infertility source unknown and have obtained positive pregnancy in any of the first 4 treatments IUI
IUI unsuccessful pregnancy
42 samples of semen from a program attached to patients for insemination Male indication Normal / slightly abnormal sperm count or infertility source unknown and after undergoing maximum 4 cycles have unsuccessfully IUI indication of IVF / ICSI.



Primary Outcome Measures :
  1. Identify, by Lipidomics approaches, biochemical markers of fertility / infertility sperm and seminal plasma linking the success or failure of the artificial insemination [ Time Frame: 18 months ]

    Levels of docosahexaenoic acid (DHA) and acid eicosapentaenoic (EPA) in 42 semen samples:

    • With positive pregnancy in any of the first 4 treatments of artificial insemination.
    • Gestacion Negative in artificial insemination
    • Assigned to the program-donors donation


Secondary Outcome Measures :
  1. Descriptive analysis of semen parameters versus DHA and EPA levels [ Time Frame: 18 months ]

    Correlation analysis of seminal variables:

    sperm count, motility and morphology percent compared to the levels of DHA and EPA obtained.

    Assuming normal distribution continuous variables, ANOVA test apply. If the normality assumption failed an Kruskal-Wallis test was applied.




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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo cycles of artificial insemination with own semen. Donor semen samples are intended for cycles of artificial insemination of donor Once the technical and knowing the value of the ßhCG (indicating pregnancy hormone)determined up to a maximum of 4 treatments, the population for this study were divided into three groups
Criteria

Inclusion Criteria Group A women donor group

  • Fallopian unobstructed Men donor group
  • Appear as sperm donor
  • Age between 18-35 years
  • Sexual abstinence 3-5 days

Exclusion Criteria Group A:

  • Uterine malformations (fibroids, adenomyosis, uterine malformations or acquired congenital) and fallopian tubes (tubal occlusion)
  • Obesity BMI (Body Mass Index)> 30 kg / m2
  • Presence of altered tubal toxic habits (smoking> 15 cigarettes per day, alcohol or drug abuse).

Inclusión / Exclusion Criteria Group B and C:

  • ≤ 38 years
  • Natural cycles and stimulated
  • The criteria inclusion / exclusion group A
  • Time sterility not exceeding three years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704936


Contacts
Contact: Fernando Quintana, MD +34 944806020 ext 20504 fernando.quintana@ivi.es
Contact: Marcos PI Ferrando, MD +34 944806020 ext 20503 marcos.ferrando@ivi.es

Locations
Spain
IVI Bilbao Recruiting
Leioa, Vizcaya, Spain, 48940
Contact: Fernando Quintana    +34 944806020 ext 20504    fernando.quintana@ivi.es   
Contact: Marcos Ferrando    +34 944 806020 ext 20503    marcos.ferrando@ivi.es   
Sponsors and Collaborators
IVI Bilbao
Basque Country University
Investigators
Principal Investigator: Marcos Ferrando, MD IVI Bilbao

Responsible Party: IVI Bilbao
ClinicalTrials.gov Identifier: NCT02704936     History of Changes
Other Study ID Numbers: 505-BIO-035-MF
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female