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

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Completed

CT.gov ID

NCT03034941

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity PCOS	Drug: Metformin Drug: Liraglutide + metformin	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: metformin group Drug: metformin	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 Other Names: Glucophage tablets
Active Comparator: COMBI group Drug: liraglutide + metformin	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 Other Names: Glucophage tablets Drug: 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. Other Names: Victoza 6 mg/ml solution and Glucophage tablets
No Intervention: CONTROL group control group of obese PCOS patients without therapy

Arm

Intervention/Treatment

Active Comparator: metformin group

Drug: metformin

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

Other Names:

Glucophage tablets

Active Comparator: COMBI group

Drug: liraglutide + metformin

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

Other Names:

Glucophage tablets

Drug: 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.

Other Names:

Victoza 6 mg/ml solution and Glucophage tablets

No Intervention: CONTROL group

control group of obese PCOS patients without therapy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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. [patients were introduced to IVF one month after completed weight loss therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts 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