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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin group | Active Comparator | Drug: metformin |
|
| COMBI group | Active Comparator | Drug: liraglutide + metformin |
|
| CONTROL group | No Intervention | control group of obese PCOS patients without therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The main outcome was change in BMI | Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eda Vrtacnik Bokal, professor | University Medical Centre Ljubljana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ljubljana | Ljubljana | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24362411 | Background | 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. | |
| 18692801 |
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Data are going to be available for other researchers if needed after the evaluation of this study.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069450 | Liraglutide |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D052216 |
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|
| Liraglutide + metformin | Drug | 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. |
|
|
| patients were introduced to IVF one month after completed weight loss therapy |
| Jungheim 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. |
| 21500991 | Background | Depalo 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004364 | Pharmaceutical Preparations |