NCT02671344

Brief Summary

Microarray experiments to assess the expression of thousands of genes providing vast amount of information. Because the molecular requirements in the different processes related to playback,on the hypothesis that there may be more apt semen samples for technical or other assuming molecular differences in RNA content messengers or gene expression profile between the They getting semen samples in gestation versus those who do not. In an attempt to give a functional data obtained view, it is to find out how many of these genes in donors who have obtained gestation, they are differentially expressed in playback related processes against those donors who did not get pregnant.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

January 25, 2016

Last Update Submit

February 11, 2020

Conditions

Donor Site Complication

Outcome Measures

Primary Outcomes (1)

  • Detecting gene expression differences in RNA content messengers or gene expression profile between the semen samples versus those who get pregnant when you do not.

    mRNA whole is characterized by using microarrays, in semen samples from donors included in the donation program of the clinic. By using bioinformatics tools Gene Ontology search listings of genes related to reproduction for the interpretation and identification of those who are involved in the different processes will be performed

    15 months

Study Arms (3)

IAD group

Sperm donors from donation program who have obtained three pregnancies Sperm donors from donation program that have not generated gestation IAD group 'Determination of gene profiles using arrays semen'

Other: Determination of gene profiles using arrays semen

FIV group

Sperm donors from donation program who have obtained three pregnancies Sperm donors from donation program that have not generated gestation FIV group of gene profiles using arrays semen'

Other: Determination of gene profiles using arrays semen

ICSI group

Sperm donors from donation program who have obtained three pregnancies Sperm donors from donation program that have not generated gestation 'Determination of gene profiles using arrays semen'

Other: Determination of gene profiles using arrays semen

Interventions

Determination of gene profiles using arrays semenOTHER

Determination of gene profiles characterizing the set of mRNA and functional interpretation of the resulting list of genes.

FIV groupIAD groupICSI group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Open retrospective study of 30 semen donors. Comparisons were made of gene expression profile between the IAD, IVF and ICSI groups according to the clinical outcomes of pregnancy. * The donor recruitment will be made according to standard protocols rather Bilbao IVI centers will no visit, checking out additional analytical donation program to the donor is attached. * By SIVIS data base, the results of different gestation is collected reproductive treatments that allow the allocation to the comparison groups gene profile.

You may qualify if:

  • IAD group Younger than 37 years, natural cycles and stimulated apparently no problem of infertility as follows:
  • Polycystic ovary syndrome.
  • Endometriosis.
  • ovarian failure.
  • Lack of tubal patency (Both fallopian tubes must submit permeability).
  • altered hormonal profiles (High levels of FSH, LH, testosterone and androstenedione).
  • Anovulation.
  • Uterine malformations (uterine septum, bicorne, didelphic and unicorn.)
  • Ovarian cysts or tumors.
  • Pelvic inflammatory disease.
  • Obesity (Women with a BMI\> 30).
  • Thyroid Disease.
  • Diabetes mellitus.
  • renal or adrenal disease.
  • toxic habits (smoking, alcohol or drug abuse).
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Bilbao

Leioa, Vizcaya, 48940, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Determination of gene profiles characterizing the set of mRNA from donor seminal samples

Study Officials

  • Fernando Quintana

    IVI Bilbao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 2, 2016

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

December 1, 2017

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

ES(1)