Liraglutide Treatment in Obese Infertile PCOS Women
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorPeking University Third Hospital
About this trial
Liraglutide, a hypoglycemic drug, can reduce weight and improve insulin resistance while stabilizing blood glucose metabolism without increasing the risk of hypoglycemia, and has been approved by the State Food and Drug Administration of China and the US Food and Drug Administration for the treatment of obesity. Polycystic ovary syndrome (PCOS) is the main cause of female anovulatory infertility, and it is also a high-risk group of obesity. Previous studies have suggested that liraglutide improves glucose metabolism, body weight, and inflammation levels in obese women with PCOS, and improves sex hormone profiles and menstrual cycles, possibly contributing to increased fertility.
Therefore, this project intends to test the following hypothesis through a large sample randomized controlled trial in obese and infertile PCOS women who are assisted by in vitro fertilization-frozen embryo transfer (IVF-FET), using liraglutide before transplantation to reduce weight can improve the live birth rate of assisted reproduction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with polycystic ovary syndrome (PCOS) who meet the Rotterdam diagnostic criteria.
Aged 20-40 years;
25 kg/m2 ≤ BMI ≤ 35 kg/m2;
Have not used any anti-diabetes or weight-loss medications (metformin excluded) within the past 3 months;
Disqualifiers
Diabetic ketoacidosis or other acute complications of diabetes;
HbA1c ≥ 9.0% before enrollment;
Using drugs that affect appetite or nutrient absorption within the past 2 months (metformin excluded);
Uncontrolled hyperthyroidism or hypothyroidism, hypertension, systemic autoimmune diseases, etc. that may affect pregnancy and fetal development;
Trial design
Design model
Parallel
Treatments tested in this trial
Liraglutide and metformin
DrugLiraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
Metformin
DrugMetformin 1500 mg/day until pregnancy
Treatment groups
890 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Live birth rate associated with single cycle frozen embryo transfer
The rate of live birth of intervention and control groups
Time frame
At deliverySecondary outcomes
1
Clinical pregnancy rate of single cycle frozen embryo transfer
Viable intrauterine pregnancy confirmed by ultrasound
Time frame
Thirty days after the embryo transplantation2
Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy
Newly diagnosed diabetes or gestational diabetes at 28 weeks of pregnancy confirmed by 75 g oral glucose tolerance test。
Time frame
At 28 weeks of pregnancy3
Pregnancy outcome and complications
Rate of miscarriage, multiple pregnancies, pregnancy induced hypertension, preeclampsia, HELLP syndrome, prematurity (\< 37 weeks), macrosomia (birth weight \> 4 kg), induction of labour, prolonged duration of labour, caesarean section, assisted delivery, peripartum increased blood loss (≥ 800 ml).
Time frame
From baseline to delivery4
Birth weight for gestational age
Birth weight percentile for gestational age for neonatal sex
Time frame
At deliveryOther outcomes
1
Weight
Measured by the same weight scale
Time frame
At baseline, and week 122
Oral glucose tolerance test
oral glucose tolerance test was conducted to test glucose metabolism
Time frame
At baseline, week 12, 28 weeks of pregnant, six weeks after delivery3
HbA1c
Glycosylated hemoglobin
Time frame
At baseline and week124
Rate of insulin usage during pregancy
Time frame
Throughout pregnancySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov