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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03353948
Other study ID # Obese PCOS IVF
Secondary ID
Status Completed
Phase Phase 4
First received November 15, 2017
Last updated November 21, 2017
Start date September 1, 2014
Est. completion date September 1, 2016

Study information

Verified date November 2017
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 1, 2016
Est. primary completion date May 31, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 37 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other The other outcomes was changes changes in fasting concentrations of glucose 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.
Other The other outcomes was changes changes in fasting concentrations of insulin 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 Other outcome was change in blood concentration of testosterone 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 Other outcome was change in blood concentration in androstenedione. 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 Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin). 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. ]
Primary IVF pregnancy rates Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound 14 days
Primary 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. ]
Primary 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 Oocyte nuclear maturation The number of metaphase 2 oocytes, metaphase 1 oocytes, and germinal vesicles 2 days
Secondary Embryo quality 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
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