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

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ClinicalTrials.gov Identifier: NCT02671344
Recruitment Status : Terminated (could not be obtained enough sperm RNA is highly fragmented and very difficult to purify.)
First Posted : February 2, 2016
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Fundación IVI
Information provided by (Responsible Party):
IVI Bilbao

Tracking Information
First Submitted Date January 25, 2016
First Posted Date February 2, 2016
Last Update Posted Date February 12, 2020
Actual Study Start Date April 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2016)
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. [ Time Frame: 15 months ]
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
Original Primary Outcome Measures
 (submitted: January 28, 2016)
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. [ Time Frame: 2016 ]
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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determining the Genetic Profile in Semen Donors With Pregnancy, Donor Versus no Pregnancy Obtained in TRA
Official Title Determination of Gene Profiling in Semen Donors With Pregnancy Versus no Donor Gestation, Obtained in Assisted Reproduction Treatments
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.

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
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Determination of gene profiles characterizing the set of mRNA from donor seminal samples
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.
Condition 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.
Study Groups/Cohorts
  • 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'
    Intervention: 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'
    Intervention: 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'
    Intervention: Other: Determination of gene profiles using arrays semen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 11, 2020)
14
Original Estimated Enrollment
 (submitted: January 28, 2016)
30
Actual Study Completion Date December 1, 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

-

Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02671344
Other Study ID Numbers 1406-BIO-036-FQ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party IVI Bilbao
Study Sponsor IVI Bilbao
Collaborators Fundación IVI
Investigators
Principal Investigator: Fernando Quintana IVI Bilbao
PRS Account IVI Bilbao
Verification Date February 2020