Short Term Weight Loss With Liraglutide and Metformin in Infertile Obese PCOS Patients

Obesity Clinical Trial

Official title:

Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034941
• Other study ID #: Obesity,PCOS and IVF
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2017
• Last updated: January 25, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• PCOS
• Weight Loss

Intervention

Drug:
• Metformin
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 + metformin
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.

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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
Secondary	Impact of the short term weight loss 5% or more before IVF on oocyte number of blastocysts in infertile obese PCOS population.		patients were introduced to IVF one month after completed weight loss therapy