OverweightNCT00934765
Effect of Weight Loss on Reproductive Function in Overweight Men
An observational study of Overweight and Obesity, run by Oslo University College at 1 site in Norway.
Trial summary
Obesity has been found to be a risk factor for female infertility. Studies have indicated that obese men often have poor semen quality and require increased time to make partner pregnant. To date, no studies have investigated the effect of weight reduction on male fertility. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- weight loss
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2008to Jun 2016
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese and overweight men that are planing to loss weight by diet and/or lifestyle changes or gastric by-pass surgery.
Who may be able to join
- Age > 18
- BMI > 27 kg/m2
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University College
Oslo, N-0130
Trine B. Haugen, PhD, +47 45 3023, Trine.B.Haugen@hioa.no
Oliwia Witczak, PhD, +47 67236277, Oliwia.Witczak@hioa.no
About this study
Official title: Effect of Weight Loss on Reproductive Function in Overweight Men.
Obesity has been found to be a risk factor for female infertility. Studies have indicated that obese men often have poor semen quality and require increased time to make partner pregnant. To date, no studies have investigated the effect of weight reduction on male fertility. The purpose of this study is to investigate the effect of weight reduction in overweight and obese men on their reproductive function.
- Conditions
- Overweight, Obesity
- Being tested
- weight loss
- Keywords
- overweight, obesity, male, fertility
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight lossBehavioural
self-directed weight loss, guided weight loss, weight loss by gastric by-pass surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
weight, height, % body fat, sperm (volume, concentration, motility, morphology, vitality), sperm DNA integrity, steroid hormones, gonadotropins, blood glucose, HbA1c, mCRP, lipids, adiponectins, fatty acid composition in serum and sperm phospholipids
Measured: minimum three months
Secondary outcomes (1)
genetic variations in genes involved in metabolism and reproduction
Measured: no time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startSep 2008
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University College
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, The Hospital of Vestfold, Tartu University Hospital
- Responsible party
- Principal investigator, Oliwia Witczak, Oslo Metropolitan University
- Investigators
- Trine B. Haugen, PhD, Study chair, Oslo University CollegeOliwia Witczak, PhD, Principal investigator, Oslo University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934765
- Sponsor's protocol ID
- HiO 08/220b
- Status last verified
- Mar 2014
- First submitted
- 7 Jul 2009
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss on Reproductive Function in Overweight Men.
- ClinicalTrials.gov ID
- NCT00934765
- Acronym / sponsor ID
- HiO 08/220b
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, male, fertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oslo University CollegeUniversity, hospital or other
- Collaborators
- Oslo University Hospital, The Hospital of Vestfold, Tartu University Hospital
- Study start
- Sep 2008
- Primary completion
- Jun 2016 (estimated)
- First posted
- 8 Jul 2009 (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.
Obesity has been found to be a risk factor for female infertility. Studies have indicated that obese men often have poor semen quality and require increased time to make partner pregnant. To date, no studies have investigated the effect of weight reduction on male fertility. The purpose of this study is to investigate the effect of weight reduction in overweight and obese men on their reproductive function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese and overweight men that are planing to loss weight by diet and/or lifestyle changes or gastric by-pass surgery.
Key inclusion criteria (2 listed)
- Age > 18
- BMI > 27 kg/m2
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 |
|---|---|---|
| weight lossself-directed weight loss, guided weight loss, weight loss by gastric by-pass surgery | Behavioural | – |
Primary outcome
weight, height, % body fat, sperm (volume, concentration, motility, morphology, vitality), sperm DNA integrity, steroid hormones, gonadotropins, blood glucose, HbA1c, mCRP, lipids, adiponectins, fatty acid composition in serum and sperm phospholipids
Time frame: minimum three months
1 secondary outcome
genetic variations in genes involved in metabolism and reproduction
Time frame: no time frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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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.
Trine B. Haugen, PhD study chair
Oslo University College
Oliwia Witczak, PhD principal investigator
Oslo University College
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 Overweight and Obesity, run by Oslo University College at 1 site in Norway.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Apr 2015. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trine B. Haugen, PhD (+47 22453023, Trine.B.Haugen@hioa.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight, height, % body fat, sperm (volume, concentration, motility, morphology, vitality), sperm DNA integrity, steroid hormones, gonadotropins, blood glucose, HbA1c, mCRP, lipids, adiponectins, fatty acid composition in serum and sperm phospholipids (time frame: minimum three 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 21 Apr 2015.