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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03034941 |
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Date of registration:
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04/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Short Term Weight Loss With Liraglutide and Metformin in Infertile Obese PCOS Patients
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Scientific title:
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Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03034941 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Eda Vrtacnik Bokal, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Centre Ljubljana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- polycystic ovary syndrome (rotterdam criteria)
- BMI of 30 kg/m² or higher
- Infertility for IVF with normal male sperm
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
38 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Obesity
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PCOS
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Intervention(s)
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Drug: Liraglutide + metformin
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Drug: Metformin
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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]
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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]
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Secondary ID(s)
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Obesity,PCOS and IVF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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