The Effect of a Liraglutide on IVF in Obese PCOS

November 21, 2017 updated by: Vesna Salamun, University Medical Centre Ljubljana

The Effect of Liraglutide on Pregnancy Rates in Obese Women With PCOS Undergoing in Vitro Fertilization: a Pilot Randomized Study

The aim of this study was to evaluate the impact of low dose liraglutide in combination with metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and spontaneous) in infertile obese women with PCOS who had been previously poor responders regarding weight reduction with lifestyle modification and resistant to first line reproductive treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 novel medical therapy (combination of metformin and liraglutide (COMBI)) in the specific infertile obese PCOS population. GLP-1 has been investigated in regulation of reproductive system in animal models. Current observations suggest that it directly regulates kisspeptin and GnRH expression and that ovaries express GLP-1 mRNA. In obese PCOS, GLP-1 receptor agonist liraglutide provided positive effects on weight reduction and glucose homeostasis

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years old to 38 years old
  • polycystic ovary syndrome (rotterdam criteria)
  • BMI of 30 kg/m² or higher
  • Infertility
  • Before IVF

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 MEN 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 no other ovarian pathology normal male semen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metfrormin group (MET)
Drug: Metformin
Drug: MET
In the MET 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 BID per os for 12 weeks. After 1 month IVF was done.
Other Names:
  • Glucophage tbl
Active Comparator: COMBI group (COMBI)
Drug: liraglutide
Drug: COMBI
In the COMBI group the initial dose of MET was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg BID. Liraglutide 1.2 mg QD s.c. was added after first two weeks of monotherapy with MET. After 1 month IVF was done.
Other Names:
  • Victoza 6 mg/ml solution for injection in pre-filled pen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVF pregnancy rates
Time Frame: 14 days
Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound
14 days
BMI
Time Frame: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial. ]
Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial. ]
Cumulative pregnancy rates
Time Frame: The pregnancies were collected by phone interview after one year
Number of all pregnancies (IVF pregnancies and spontaneous pregnancies) per patient
The pregnancies were collected by phone interview after one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte nuclear maturation
Time Frame: 2 days
The number of metaphase 2 oocytes, metaphase 1 oocytes, and germinal vesicles
2 days
Embryo quality
Time Frame: 6 days
The embryo quality assessed by standard cleavage stage embryo grading system on day 3 of embryo culture. For any embryos grown to day 5, the embryo quality assessed by standard blastocyst grading system on day 5 of embryo culture
6 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The other outcomes was changes changes in fasting concentrations of glucose
Time Frame: Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.
The other outcomes was changes changes in fasting concentrations of insulin
Time Frame: Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.
Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.
Other outcome was change in blood concentration of testosterone
Time Frame: Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]
Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.
Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]
Other outcome was change in blood concentration in androstenedione.
Time Frame: Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.
Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.
Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).
Time Frame: Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.
Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Eda Vrtacnik Bokal, professor, UMC Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

May 31, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obese PCOS IVF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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