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

Donor Site Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02671344
• Other study ID #: 1406-BIO-036-FQ
• Status: Terminated
• Start date: April 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: February 2020
• Source: IVI Bilbao
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 1, 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Donor Site Complication

Intervention

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.

Locations

Country	Name	City	State
Spain	IVI Bilbao	Leioa	Vizcaya

Sponsors (2)

Lead Sponsor	Collaborator
IVI Bilbao	Fundación IVI

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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