Donor Site ComplicationNCT02671344
Determining the Genetic Profile in Semen Donors With Pregnancy, Donor Versus no Pregnancy Obtained in TRA
An observational study of Donor Site Complication, run by IVI Bilbao at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Donor Site Complication
- What is being tested?
- Determination of gene profiles using arrays semen
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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).
Show all 35Show fewer
- 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)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Donor Site Complication
- Being tested
- Determination of gene profiles using arrays semen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: 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' Receives: 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' Receives: Other: Determination of gene profiles using arrays semen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completion1 Dec 2017
Why it stopped: could not be obtained enough sperm RNA is highly fragmented and very difficult to purify.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor Site ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Bilbao
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación IVI
- Responsible party
- Sponsor
- Investigators
- Fernando Quintana, Principal investigator, IVI Bilbao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671344
- Sponsor's protocol ID
- 1406-BIO-036-FQ
- Status last verified
- Feb 2020
- First submitted
- 25 Jan 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Gene Profiling in Semen Donors With Pregnancy Versus no Donor Gestation, Obtained in Assisted Reproduction Treatments
- ClinicalTrials.gov ID
- NCT02671344
- Acronym / sponsor ID
- 1406-BIO-036-FQ
- Conditions
- Donor Site Complication
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: could not be obtained enough sperm RNA is highly fragmented and very difficult to purify.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- IVI BilbaoUniversity, hospital or other
- Collaborators
- Fundación IVI
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IAD group | – | Other: Determination of gene profiles using arrays semenSperm 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' |
| FIV group | – | Other: Determination of gene profiles using arrays semenSperm 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' |
| ICSI group | – | Other: Determination of gene profiles using arrays semenSperm 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' |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (35 listed)
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of gene profiles using arrays semenDetermination of gene profiles characterizing the set of mRNA and functional interpretation of the resulting list of genes. | Other | FIV group, IAD group, ICSI group |
Primary outcome
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
Results and safety
The study was stopped early (reason given: could not be obtained enough sperm RNA is highly fragmented and very difficult to purify.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Donor Site Complication
RecruitingObservational study
Donor Ankle Sensorimotor Recovery After ACL Reconstruction With a Peroneus Longus Tendon Autograft
Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction
Not yet recruitingPhase 1
A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)
Clear Cell Renal Cell Carcinoma (ccRCC)
Recruiting
Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal Stent
Postoperative Pain, Mucogingival Defects
Recruiting
Blue Light for Donor Site Healing in Burn Patients
Donor Site Complication, Burn
RecruitingPhase 1/2
Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
Cancer, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Quintana principal investigator
IVI Bilbao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Donor Site Complication, run by IVI Bilbao at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: could not be obtained enough sperm RNA is highly fragmented and very difficult to purify.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.