Weight LossNCT04989244
Infertile Polycystic Ovary Syndrome (PCOS) Women With Obesity and Lifestyle Changes
A study testing Weight loss program in people with Weight Loss, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Infertile PCOS women with obesity were included into lifestyle change weight loss program prior to inclusion to IVF procedures. They attended group as well as individual workouts and they were advised on healthy eating. 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
- Weight Loss
- What is being tested?
- Weight loss program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2019to 15 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- BMI over 30 kg/m2
- PCOS
- Primary or secondary infertility
- normal partner's semen
Who cannot join
- Other identifiable causes of infertility
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Division of gynecology, Department of human reproduction
Ljubljana, 1000
About this study
Official title: Weight Loss Program in Infertile PCOS Women With Obesity
Infertile PCOS women with obesity were included into lifestyle change weight loss program prior to inclusion to IVF procedures. They attended group as well as individual workouts and they were advised on healthy eating.
Read the detailed description
The weight loss program will consist of dietary change and exercise program which will be performed 3 times weekly.
- Conditions
- Weight Loss
- Being tested
- Weight loss program
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss programBehavioural
Women with obesity were included to the weight loss program which included physical exercise and dietary guidelines
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Body weight before and after the weight loss program will be measured.
Measured: 8 weeks
BMI (kg/m2)
BMI before and after the weight loss program will be calculated).
Measured: 8 weeks
Waist circumference (cm)
Waist circumference before and after the weight loss program will be measured.
Measured: 8 weeks
Abdominal circumference (cm)
Abdominal circumference
Measured: 8 weeks
Secondary outcomes (1)
Spontaneous conception rate
Spontaneous pregnancy rate after weight loss program will be calculated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Sep 2019
- Primary completion1 May 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency
- Responsible party
- Principal investigator, Tanja Burnik Papler, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989244
- Sponsor's protocol ID
- TBP1
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdulkhalikova D, Sustarsic A, Vrtacnik Bokal E, Jancar N, Jensterle M, Burnik Papler T. The Lifestyle Modifications and Endometrial Proteome Changes of Women With Polycystic Ovary Syndrome and Obesity. Front Endocrinol (Lausanne). 2022 Jun 22;13:888460. doi: 10.3389/fendo.2022.888460. eCollection 2022.
PubMed 35813634
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Program in Infertile PCOS Women With Obesity
- ClinicalTrials.gov ID
- NCT04989244
- Acronym / sponsor ID
- TBP1
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 4 Aug 2021 (actual)
- 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.
Infertile PCOS women with obesity were included into lifestyle change weight loss program prior to inclusion to IVF procedures. They attended group as well as individual workouts and they were advised on healthy eating.
Detailed description
The weight loss program will consist of dietary change and exercise program which will be performed 3 times weekly.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI over 30 kg/m2
- PCOS
- Primary or secondary infertility
- normal partner's semen
Key exclusion criteria (1 listed)
- Other identifiable causes of infertility
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 loss programWomen with obesity were included to the weight loss program which included physical exercise and dietary guidelines | Behavioural | – |
Primary outcome
Body weight (kg)
Time frame: 8 weeks
Body weight before and after the weight loss program will be measured.
BMI (kg/m2)
Time frame: 8 weeks
BMI before and after the weight loss program will be calculated).
Waist circumference (cm)
Time frame: 8 weeks
Waist circumference before and after the weight loss program will be measured.
Abdominal circumference (cm)
Time frame: 8 weeks
Abdominal circumference
1 secondary outcome
Spontaneous conception rate
Time frame: 3 months
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 4 Aug 2021.
- Derived from this study: PubMed 35813634Abdulkhalikova D, Sustarsic A, Vrtacnik Bokal E, Jancar N, Jensterle M, Burnik Papler T. The Lifestyle Modifications and Endometrial Proteome Changes of Women With Polycystic Ovary Syndrome and Obesity. Front Endocrinol (Lausanne). 2022 Jun 22;13:888460. doi: 10.3389/fendo.2022.888460. eCollection 2022.
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss program in people with Weight Loss, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 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: finished, as of the sponsor's last update on 4 Aug 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 Slovenia. 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.
What does the primary outcome measure?
Body weight (kg) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04989244, which also lists 1 linked publication.
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 4 Aug 2021.