ObesityPhase 4NCT03034941
Short Term Weight Loss With Liraglutide and Metformin in Infertile Obese PCOS Patients
A Phase 4 study testing Metformin and Liraglutide + metformin in people with Obesity and PCOS, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The aim of this study was to evaluate the impact of short-term weight reduction achieved with 12-week intervention with metformin alone or in combination with liraglutide on oocyte maturity and embryo quality in infertile obese PCOS population. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- What is being tested?
- Metformin and Liraglutide + metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSlovenia
- Study dates
- Apr 2014to Dec 2016
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- polycystic ovary syndrome (rotterdam criteria)
- BMI of 30 kg/m² or higher
- Infertility for IVF with normal male sperm
Who cannot join
- type 1 or type 2 diabetes mellitus
- history of carcinoma
- Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- personal or family history of multiple endocrine neoplasia 2
- significant cardiovascular, kidney or hepatic disease
- the use of medications known or suspected to affect reproductive or metabolic functions
- the use of statins, within 90 days prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients
The aim of this study was to evaluate the impact of short-term weight reduction achieved with 12-week intervention with metformin alone or in combination with liraglutide on oocyte maturity and embryo quality in infertile obese PCOS population.
Read the detailed description
Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in particular when PCOS is linked to obesity. Obese PCOS has poor IVF outcomes associated with impaired oocyte and embryo parameters and morphology. The purpose of this pilot prospective study was to investigate the effect of the antiobesity medical therapy (combination of metformin and liraglutide (COMBI)) on short time weight loss in the specific infertile obese PCOS population. Additionally, we analyzed eventual impact of the short term weight loss 5% or more before IVF on oocyte maturity and embryo quality in infertile obese PCOS population.
- Being tested
- Metformin, Liraglutide + metformin
- Keywords
- Obesity, PCOS, Infertility, Liraglutide, Metformin, IVF
- Medical subject headings
- Obesity, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage tablets
In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg twice per day per os for 12 weeks
Liraglutide + metforminDrug
Also called Victoza 6 mg/ml solution and Glucophage tablets
In the COMBI group the initial dose of metformin was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg twice per day. Liraglutide 1.2 mg once per day s.c. was added after first two weeks of monotherapy with metformin.
| Study group | Role | What they receive |
|---|---|---|
| metformin group | Active comparator | Drug: metformin Receives: Drug: Metformin |
| COMBI group | Active comparator | Drug: liraglutide + metformin Receives: Drug: Metformin; Drug: Liraglutide + metformin |
| CONTROL group | No intervention | control group of obese PCOS patients without therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome was change in BMI
Measured: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial.
Secondary outcomes (2)
Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population.
Measured: patients were introduced to IVF one month after completed weight loss therapy
Impact of the short term weight loss 5% or more before IVF on oocyte number of blastocysts in infertile obese PCOS population.
Measured: patients were introduced to IVF one month after completed weight loss therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Janez, University Medical Centre Ljubljana
- Investigators
- Eda Vrtacnik Bokal, professor, Study chair, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034941
- Sponsor's protocol ID
- Obesity,PCOS and IVF
- Status last verified
- Dec 2016
- First submitted
- 4 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data are going to be available for other researchers if needed after the evaluation of this study.
Publications
Jensterle Sever M, Kocjan T, Pfeifer M, Kravos NA, Janez A. Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin. Eur J Endocrinol. 2014 Feb 7;170(3):451-9. doi: 10.1530/EJE-13-0797. Print 2014 Mar.
PubMed 24362411Jungheim ES, Lanzendorf SE, Odem RR, Moley KH, Chang AS, Ratts VS. Morbid obesity is associated with lower clinical pregnancy rates after in vitro fertilization in women with polycystic ovary syndrome. Fertil Steril. 2009 Jul;92(1):256-61. doi: 10.1016/j.fertnstert.2008.04.063. Epub 2008 Aug 9.
PubMed 18692801Depalo R, Garruti G, Totaro I, Panzarino M, Vacca MP, Giorgino F, Selvaggi LE. Oocyte morphological abnormalities in overweight women undergoing in vitro fertilization cycles. Gynecol Endocrinol. 2011 Nov;27(11):880-4. doi: 10.3109/09513590.2011.569600. Epub 2011 Apr 18.
PubMed 21500991
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients
- ClinicalTrials.gov ID
- NCT03034941
- Acronym / sponsor ID
- Obesity,PCOS and IVF
- Keywords
- Obesity, PCOS, Infertility, Liraglutide, Metformin, IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jan 2017 (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.
The aim of this study was to evaluate the impact of short-term weight reduction achieved with 12-week intervention with metformin alone or in combination with liraglutide on oocyte maturity and embryo quality in infertile obese PCOS population.
Detailed description
Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in particular when PCOS is linked to obesity. Obese PCOS has poor IVF outcomes associated with impaired oocyte and embryo parameters and morphology. The purpose of this pilot prospective study was to investigate the effect of the antiobesity medical therapy (combination of metformin and liraglutide (COMBI)) on short time weight loss in the specific infertile obese PCOS population. Additionally, we analyzed eventual impact of the short term weight loss 5% or more before IVF on oocyte maturity and embryo quality in infertile obese PCOS population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| metformin group | Active comparator | Drug: MetforminDrug: metformin |
| COMBI group | Active comparator | Drug: Metformin, Drug: Liraglutide + metforminDrug: liraglutide + metformin |
| CONTROL group | No intervention | –control group of obese PCOS patients without therapy |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- polycystic ovary syndrome (rotterdam criteria)
- BMI of 30 kg/m² or higher
- Infertility for IVF with normal male sperm
Key exclusion criteria (7 listed)
- type 1 or type 2 diabetes mellitus
- history of carcinoma
- Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- personal or family history of multiple endocrine neoplasia 2
- significant cardiovascular, kidney or hepatic disease
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 |
|---|---|---|
| MetforminAlso: Glucophage tabletsIn the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg twice per day per os for 12 weeks | Drug | COMBI group, metformin group |
| Liraglutide + metforminAlso: Victoza 6 mg/ml solution and Glucophage tabletsIn the COMBI group the initial dose of metformin was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg twice per day. Liraglutide 1.2 mg once per day s.c. was added after first two weeks of monotherapy with metformin. | Drug | COMBI group |
Primary outcome
The main outcome was change in BMI
Time frame: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial.
2 secondary outcomes
Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population.
Time frame: patients were introduced to IVF one month after completed weight loss therapy
Impact of the short term weight loss 5% or more before IVF on oocyte number of blastocysts in infertile obese PCOS population.
Time frame: patients were introduced to IVF one month after completed weight loss therapy
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 27 Jan 2017.
- Background: PubMed 24362411Jensterle Sever M, Kocjan T, Pfeifer M, Kravos NA, Janez A. Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin. Eur J Endocrinol. 2014 Feb 7;170(3):451-9. doi: 10.1530/EJE-13-0797. Print 2014 Mar.
- Background: PubMed 18692801Jungheim ES, Lanzendorf SE, Odem RR, Moley KH, Chang AS, Ratts VS. Morbid obesity is associated with lower clinical pregnancy rates after in vitro fertilization in women with polycystic ovary syndrome. Fertil Steril. 2009 Jul;92(1):256-61. doi: 10.1016/j.fertnstert.2008.04.063. Epub 2008 Aug 9.
- Background: PubMed 21500991Depalo R, Garruti G, Totaro I, Panzarino M, Vacca MP, Giorgino F, Selvaggi LE. Oocyte morphological abnormalities in overweight women undergoing in vitro fertilization cycles. Gynecol Endocrinol. 2011 Nov;27(11):880-4. doi: 10.3109/09513590.2011.569600. Epub 2011 Apr 18.
- Individual participant dataSharing planned: Yes. Data are going to be available for other researchers if needed after the evaluation of this study.
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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.
Eda Vrtacnik Bokal, professor study chair
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Liraglutide + metformin in people with Obesity and PCOS, 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 3 inclusion and 7 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 27 Jan 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The main outcome was change in BMI (time frame: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial.). 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 NCT03034941, which also lists 3 linked publications.
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 27 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.