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

NCT ID: NCT02671344

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Donor Site Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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'

Determination of gene profiles using arrays semen

Intervention Type OTHER

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'

Determination of gene profiles using arrays semen

Intervention Type OTHER

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'

Determination of gene profiles using arrays semen

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación IVI

OTHER

Sponsor Role collaborator

IVI Bilbao

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando Quintana

Role: PRINCIPAL_INVESTIGATOR

IVI Bilbao

Locations

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IVI Bilbao

Leioa, Vizcaya, Spain

Site Status

Countries

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Spain

Other Identifiers

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1406-BIO-036-FQ

Identifier Type: -

Identifier Source: org_study_id

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