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

Primary Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02704936
• Other study ID #: 505-BIO-035-MF
• Status: Withdrawn
• Start date: December 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2021
• Source: IVI Bilbao
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Primary Infertility

Locations

Country	Name	City	State
Spain	IVI Bilbao	Leioa	Vizcaya

Sponsors (2)

Lead Sponsor	Collaborator
IVI Bilbao	Basque Country University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify, by Lipidomics approaches, biochemical markers of fertility / infertility sperm and seminal plasma linking the success or failure of the artificial insemination	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	18 months
Secondary	Descriptive analysis of semen parameters versus DHA and EPA levels	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.	18 months