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

Primary Purpose

Obesity, PCOS

Status

Completed

Phase

Phase 4

Locations

Slovenia

Study Type

Interventional

Intervention

Metformin

Liraglutide + metformin

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, PCOS, Infertility, Liraglutide, Metformin, IVF

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University Medical Center Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

metformin group

COMBI group

CONTROL group

Arm Description

Drug: metformin

Drug: liraglutide + metformin

control group of obese PCOS patients without therapy

Outcomes

Primary Outcome Measures

The main outcome was change in BMI

Secondary Outcome Measures

Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population.

Impact of the short term weight loss 5% or more before IVF on oocyte number of blastocysts in infertile obese PCOS population.

Full Information

NCT ID

NCT03034941

First Posted

January 4, 2017

Last Updated

January 25, 2017

Sponsor

University Medical Centre Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT03034941

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, PCOS

Keywords

Obesity, PCOS, Infertility, Liraglutide, Metformin, IVF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

metformin group

Arm Type

Active Comparator

Arm Description

Drug: metformin

Arm Title

COMBI group

Arm Type

Active Comparator

Arm Description

Drug: liraglutide + metformin

Arm Title

CONTROL group

Arm Type

No Intervention

Arm Description

control group of obese PCOS patients without therapy

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage tablets

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Liraglutide + metformin

Other Intervention Name(s)

Victoza 6 mg/ml solution and Glucophage tablets

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eda Vrtacnik Bokal, professor

Organizational Affiliation

University Medical Centre Ljubljana

Official's Role

Study Chair

Facility Information:

Facility Name

University Medical Center Ljubljana

City

Ljubljana

Country

Slovenia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data are going to be available for other researchers if needed after the evaluation of this study.

Citations:

PubMed Identifier

24362411

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. Print 2014 Mar.

Results Reference

background

PubMed Identifier

18692801

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. Epub 2008 Aug 9.

Results Reference

background

PubMed Identifier

21500991

Citation

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.

Results Reference

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

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