Determining the Genetic Profile in Semen Donors With Pregnancy, Donor Versus no Pregnancy Obtained in TRA

Determination of Gene Profiling in Semen Donors With Pregnancy Versus no Donor Gestation, Obtained in Assisted Reproduction Treatments

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.

Study Overview

• Status: Terminated
• Conditions: Donor Site Complication
• Intervention / Treatment: Other: Determination of gene profiles using arrays semen

Detailed Description

MRNA assembly is characterized by using microarrays on semen samples from donors included in the donation program of the clinic.

This process is performed in donors who have generated at least 3 pregnancies compared those samples, however, were not a function of gestation assisted reproduction technique used.

Consequently, differential expression of genes are identified in assisted reproduction treatment cycles from IAD, IVF or ICSI.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Spain
  • Vizcaya
    • Leioa, Vizcaya, Spain, 48940
      • IVI Bilbao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

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).

IVF group Couples who undergo IVF egg donation invoking the program. Therefore, they try to cycles in which two gametes were donors. All egg donors should be fertility proven, it is that must have been able to take shape within the program of egg donation or naturally. The recipient women (patients) should not present

• Endometriosis.
• Uterine malformations (uterine septum, bicorne, didelphic and unicorn.)
• previous implantation failures.
• cysts, polyps or uterine 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)

ICSI group Couples who undergo ICSI invoking the egg donation program. In addition, all donors oocytes must be of proven fertility, this being that should have been able to take shape within the egg donation program or naturally. The recipient women (patients) should not present

• Endometriosis.
• Uterine malformations (uterine septum, bicorne, didelphic and unicorn.)
• previous implantation failures.
• cysts, polyps or uterine 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)

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Determination of gene profiles characterizing the set of mRNA and functional interpretation of the resulting list of genes.
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; Determination of gene profiles characterizing the set of mRNA and functional interpretation of the resulting list of genes.
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; Determination of gene profiles characterizing the set of mRNA and functional interpretation of the resulting list of genes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IVI Bilbao
• Collaborators: Fundación IVI
• Investigators: Principal Investigator: Fernando Quintana, IVI Bilbao

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1406-BIO-036-FQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED