The Effect of a Liraglutide on IVF in Obese PCOS

NCT03353948 | Completed Phase 4

• 1 other identifier: Obese PCOS IVF
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovary Syndrome; Obesity; Infertility, Female

Keywords

Polycystic Ovary Syndrome; Obesity; Infertility; IVF

Outcome Measures

Primary Outcomes (3)

• IVF pregnancy rates

  Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound

  14 days

• BMI

  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

  Number of all pregnancies (IVF pregnancies and spontaneous pregnancies) per patient

  The pregnancies were collected by phone interview after one year

Secondary Outcomes (2)

• Oocyte nuclear maturation

  2 days

• Embryo quality

  6 days

Other Outcomes (5)

• The other outcomes was changes changes in fasting concentrations of glucose

  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

  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

  Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]

Study Arms (2)

Metfrormin group (MET)

ACTIVE COMPARATOR

Drug: Metformin

Drug: MET

COMBI group (COMBI)

ACTIVE COMPARATOR

Drug: liraglutide

Drug: COMBI

Interventions

MET DRUG

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.

Also known as: Glucophage tbl

Metfrormin group (MET)

COMBI DRUG

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.

Also known as: Victoza 6 mg/ml solution for injection in pre-filled pen

COMBI group (COMBI)

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Related Publications (2)

• 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.

  PMID: 24362411 BACKGROUND

• Salamun V, Rizzo M, Lovrecic L, Hocevar K, Papler Burnik T, Janez A, Jensterle M, Vrtacnik Bokal E, Peterlin B, Maver A. The Endometrial Transcriptome of Metabolic and Inflammatory Pathways During the Window of Implantation Is Deranged in Infertile Obese Polycystic Ovarian Syndrome Women. Metab Syndr Relat Disord. 2022 Sep;20(7):384-394. doi: 10.1089/met.2021.0149. Epub 2022 Jul 13.

  PMID: 35834645 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Infertility, Female; Infertility

Interventions

Liraglutide; Solutions; Injections

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Eda Vrtacnik Bokal, professor

  UMC Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 27, 2017
• Study Start: September 1, 2014
• Primary Completion: May 31, 2016
• Study Completion: September 1, 2016
• Last Updated: November 27, 2017

Record last verified: 2017-11