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The Effect of a Liraglutide on IVF in Obese PCOS

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ClinicalTrials.gov Identifier: NCT03353948
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Vesna Salamun, University Medical Centre Ljubljana

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Obesity Infertility, Female Drug: MET Drug: COMBI 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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Liraglutide on Pregnancy Rates in Obese Women With PCOS Undergoing in Vitro Fertilization: a Pilot Randomized Study
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

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 Name: 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 Name: Victoza 6 mg/ml solution for injection in pre-filled pen




Primary Outcome Measures :
  1. IVF pregnancy rates [ Time Frame: 14 days ]
    Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. Oocyte nuclear maturation [ Time Frame: 2 days ]
    The number of metaphase 2 oocytes, metaphase 1 oocytes, and germinal vesicles

  2. 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


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353948


Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Study Chair: Eda Vrtacnik Bokal, professor UMC Ljubljana

Publications:
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Responsible Party: Vesna Salamun, MD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03353948     History of Changes
Other Study ID Numbers: Obese PCOS IVF
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vesna Salamun, University Medical Centre Ljubljana:
Polycystic Ovary Syndrome
Obesity
Infertility
IVF

Additional relevant MeSH terms:
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Infertility
Polycystic Ovary Syndrome
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists