Primary InfertilityNCT02704936
Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination
An observational study of Primary Infertility, run by IVI Bilbao at 1 site in Spain.
Trial summary
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI) Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Infertility
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Oct 2018
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who undergo cycles of artificial insemination with own semen. Donor semen samples are intended for cycles of artificial insemination of donor Once the technical and knowing the value of the ßhCG (indicating pregnancy hormone)determined up to a maximum of 4 treatments, the population for this study were divided into three groups
Who may be able to join
- Fallopian unobstructed Men donor group
- Appear as sperm donor
- Age between 18-35 years
- Sexual abstinence 3-5 days
Who cannot join
- Uterine malformations (fibroids, adenomyosis, uterine malformations or acquired congenital) and fallopian tubes (tubal occlusion)
- Obesity BMI (Body Mass Index)> 30 kg / m2
- Presence of altered tubal toxic habits (smoking> 15 cigarettes per day, alcohol or drug abuse).
- Inclusión / Exclusion Criteria Group B and C:
- ≤ 38 years
- Natural cycles and stimulated
- The criteria inclusion / exclusion group A
- Time sterility not exceeding three years.
Trial locations and contacts
1 site in 1 country.
About this study
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI)
Read the detailed description
Analyze lipid profiles in samples of sperm and seminal plasma of three populations:
- male sperm donors
- men assigned to a program of assisted reproduction with normal sperm / slightly abnormal successfully in the IUI;
- attached to a program of assisted reproduction with male semen Normal / slightly abnormal unsuccessfully in IUI
Establish partnerships between the composition of fatty acids, especially fatty acids polyunsaturated (PUFA) of the omega-3 (w3) series of samples analyzed parameterssemen and results of the IA to identify biochemical markers of fertility.
Assess markers found by checking the increase in the rate of success in the IA.
- Conditions
- Primary Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Male donor | 42 samples of semen from male donor attached to a donation program Normal sperm count as WHO 2010. | |
| IUI positive pregnancy | 42 samples of semen from a program attached to patients for insemination Male indication Normal / slightly abnormal sperm count or infertility source unknown and have obtained positive pregnancy in any of the first 4 treatments IUI | |
| IUI unsuccessful pregnancy | 42 samples of semen from a program attached to patients for insemination Male indication Normal / slightly abnormal sperm count or infertility source unknown and after undergoing maximum 4 cycles have unsuccessfully IUI indication of IVF / ICSI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility sperm and seminal plasma linking the success or failure of the artificial insemination
Levels of docosahexaenoic acid (DHA) and acid eicosapentaenoic (EPA) in 42 semen samples:
- With positive pregnancy in any of the first 4 treatments of artificial insemination.
- Gestacion Negative in artificial insemination
- Assigned to the program-donors donation
Measured: 18 months
Secondary outcomes (1)
Descriptive analysis of semen parameters versus DHA and EPA levels
Correlation analysis of seminal variables:
sperm count, motility and morphology percent compared to the levels of DHA and EPA obtained.
Assuming normal distribution continuous variables, ANOVA test apply. If the normality assumption failed an Kruskal-Wallis test was applied.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: Difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InfertilityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Bilbao
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU)
- Responsible party
- Sponsor
- Investigators
- Marcos Ferrando, MD, Principal investigator, IVI Bilbao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704936
- Sponsor's protocol ID
- 505-BIO-035-MF
- Status last verified
- Sep 2021
- First submitted
- 17 Feb 2016
- Last updated
- 5 Sep 2021
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination
- ClinicalTrials.gov ID
- NCT02704936
- Acronym / sponsor ID
- 505-BIO-035-MF
- Conditions
- Primary Infertility
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IVI BilbaoUniversity, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU)
- Study start
- Dec 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 10 Mar 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.
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI)
Detailed description
Analyze lipid profiles in samples of sperm and seminal plasma of three populations:
- male sperm donors
- men assigned to a program of assisted reproduction with normal sperm / slightly abnormal successfully in the IUI;
- attached to a program of assisted reproduction with male semen Normal / slightly abnormal unsuccessfully in IUI
Establish partnerships between the composition of fatty acids, especially fatty acids polyunsaturated (PUFA) of the omega-3 (w3) series of samples analyzed parameterssemen and results of the IA to identify biochemical markers of fertility.
Assess markers found by checking the increase in the rate of success in the IA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Male donor | – | –42 samples of semen from male donor attached to a donation program Normal sperm count as WHO 2010. |
| IUI positive pregnancy | – | –42 samples of semen from a program attached to patients for insemination Male indication Normal / slightly abnormal sperm count or infertility source unknown and have obtained positive pregnancy in any of the first 4 treatments IUI |
| IUI unsuccessful pregnancy | – | –42 samples of semen from a program attached to patients for insemination Male indication Normal / slightly abnormal sperm count or infertility source unknown and after undergoing maximum 4 cycles have unsuccessfully IUI indication of IVF / ICSI. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who undergo cycles of artificial insemination with own semen. Donor semen samples are intended for cycles of artificial insemination of donor Once the technical and knowing the value of the ßhCG (indicating pregnancy hormone)determined up to a maximum of 4 treatments, the population for this study were divided into three groups
Key inclusion criteria (4 listed)
- Fallopian unobstructed Men donor group
- Appear as sperm donor
- Age between 18-35 years
- Sexual abstinence 3-5 days
Key exclusion criteria (8 listed)
- Uterine malformations (fibroids, adenomyosis, uterine malformations or acquired congenital) and fallopian tubes (tubal occlusion)
- Obesity BMI (Body Mass Index)> 30 kg / m2
- Presence of altered tubal toxic habits (smoking> 15 cigarettes per day, alcohol or drug abuse).
- ≤ 38 years
- Natural cycles and stimulated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility sperm and seminal plasma linking the success or failure of the artificial insemination
Time frame: 18 months
Levels of docosahexaenoic acid (DHA) and acid eicosapentaenoic (EPA) in 42 semen samples: * With positive pregnancy in any of the first 4 treatments of artificial insemination. * Gestacion Negative in artificial insemination * Assigned to the program-donors donation
1 secondary outcome
Descriptive analysis of semen parameters versus DHA and EPA levels
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Marcos Ferrando, MD 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 Primary Infertility, 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 5 Sep 2021. 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 withdrawn before enrolling participants, so there are no results.
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?
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility sperm and seminal plasma linking the success or failure of the artificial insemination (time frame: 18 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 5 Sep 2021.