We Will Retrospectively Assess Our Databases in Our ClinicMALE AGINGNCT00510861
Influence of Paternal Age on Assisted Reproduction Outcome
An observational study of We Will Retrospectively Assess Our Databases in Our Clinic and Instituto Valenciano de Infertilidad in Valencia (Spain), run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
In the recent years, there is an increasing tendency to the parenthood delay in developed countries, and there is not enough information available regarding the influence of the male's age on fertility. If any, the negative impact should be acting at advanced ages. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- We Will Retrospectively Assess Our Databases in Our Clinic, Instituto Valenciano de Infertilidad in Valencia (Spain), Searching for Assisted Reproduction Procedures
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Feb 2007to May 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women under 38 years old, tubal patency demonstrated by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index < 27 kg/m2.
Who cannot join
- absence of polycystic ovarian syndrome, hydrosalpinx or endometriosis.
- Cycles were studied only in couples with absence of severe male factor.
Trial locations and contacts
1 site in 1 country.
About this study
In the recent years, there is an increasing tendency to the parenthood delay in developed countries, and there is not enough information available regarding the influence of the male's age on fertility. If any, the negative impact should be acting at advanced ages.
Our aim with this work was to determine the role of paternal age on IUI results embryo quality and IVF outcome. Evenmore, in order to standardize the female factor, good quality oocytes (from fertile oocyte donors) and only first IVF cycles in young women were considered.
Read the detailed description
A retrospective study has been designed with a total number of 2204 IUI, 1286 IVF cycles and 1412 IVF cycles with donated oocytes from 2000 to 2006.
The inclusion criteria will be for IUI: women under 38 years old, tubal patency demonstrated by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index < 27 kg/m2, and absence of polycystic ovarian syndrome and endometriosis. For normal IVF cycles and oocyte donation cycles only first cycles will be analyzed. Cycles will be studied only in couples with absence of severe male factor.
- Conditions
- We Will Retrospectively Assess Our Databases in Our Clinic, Instituto Valenciano de Infertilidad in Valencia (Spain), Searching for Assisted Reproduction Procedures, IUI Standard IVF/ICSI Cycles and Ovum Donation IVF/ICSI Cycles, Who Were Referred to Our Unit to Cryopreserve Sperm During the Period, From January 2000 to December 2006
- Keywords
- male age, assisted reproduction, sperm, pregnancy outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startFeb 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for We Will Retrospectively Assess Our Databases in Our ClinicStudies 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
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Investigators
- Marcos Meseguer, PhD, Principal investigator, IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510861
- Sponsor's protocol ID
- VLC-MM-0205-507-26
- Acronym
- MALE AGING
- Status last verified
- Apr 2017
- First submitted
- 1 Aug 2007
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Paternal Age on Assisted Reproduction Outcome
- ClinicalTrials.gov ID
- NCT00510861
- Acronym / sponsor ID
- MALE AGING / VLC-MM-0205-507-26
- Conditions
- We Will Retrospectively Assess Our Databases in Our Clinic, Instituto Valenciano de Infertilidad in Valencia (Spain), Searching for Assisted Reproduction Procedures, IUI Standard IVF/ICSI Cycles and Ovum Donation IVF/ICSI Cycles, Who Were Referred to Our Unit to Cryopreserve Sperm During the Period, From January 2000 to December 2006
- Keywords
- male age, assisted reproduction, sperm, pregnancy outcome
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- May 2007 (actual)
- First posted
- 2 Aug 2007 (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.
In the recent years, there is an increasing tendency to the parenthood delay in developed countries, and there is not enough information available regarding the influence of the male's age on fertility. If any, the negative impact should be acting at advanced ages.
Our aim with this work was to determine the role of paternal age on IUI results embryo quality and IVF outcome. Evenmore, in order to standardize the female factor, good quality oocytes (from fertile oocyte donors) and only first IVF cycles in young women were considered.
Detailed description
A retrospective study has been designed with a total number of 2204 IUI, 1286 IVF cycles and 1412 IVF cycles with donated oocytes from 2000 to 2006.
The inclusion criteria will be for IUI: women under 38 years old, tubal patency demonstrated by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index < 27 kg/m2, and absence of polycystic ovarian syndrome and endometriosis. For normal IVF cycles and oocyte donation cycles only first cycles will be analyzed. Cycles will be studied only in couples with absence of severe male factor.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women under 38 years old, tubal patency demonstrated by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index < 27 kg/m2.
Key exclusion criteria (2 listed)
- absence of polycystic ovarian syndrome, hydrosalpinx or endometriosis.
- Cycles were studied only in couples with absence of severe male factor.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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 Meseguer, PhD principal investigator
IVI Valencia
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 We Will Retrospectively Assess Our Databases in Our Clinic and Instituto Valenciano de Infertilidad in Valencia (Spain), run by Instituto Valenciano de Infertilidad, IVI VALENCIA 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 28 Apr 2017.