Study Stopped
Difficulty recruiting patients
Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination
1 other identifier
observational
N/A
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedSeptember 5, 2021
September 1, 2021
2.8 years
February 17, 2016
September 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
18 months
Secondary Outcomes (1)
Descriptive analysis of semen parameters versus DHA and EPA levels
18 months
Study Arms (3)
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.
Eligibility Criteria
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
You may qualify if:
- Fallopian unobstructed Men donor group
- Appear as sperm donor
- Age between 18-35 years
- Sexual abstinence 3-5 days
You may not qualify if:
- 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
- Time sterility not exceeding three years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IVI Bilbaolead
- University of the Basque Country (UPV/EHU)collaborator
Study Sites (1)
IVI Bilbao
Leioa, Vizcaya, 48940, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Marcos Ferrando, MD
IVI Bilbao
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2016
First Posted
March 10, 2016
Study Start
December 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
September 5, 2021
Record last verified: 2021-09