Trial Title:
Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome
NCT ID:
NCT05702905
Condition:
PCOS (Polycystic Ovary Syndrome)
Semaglutide
Conditions: Official terms:
Polycystic Ovary Syndrome
Congenital Abnormalities
Syndrome
Metformin
Semaglutide
Conditions: Keywords:
PCOS
semaglutide
obese
metabolic abnormality
fertility
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
All subjects will be randomized into three groups: metformin single, semaglutide single,
both metformin and semaglutide.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Metformin Hydrochloride 500 MG
Description:
Metformin oral tablet (500mg per tablet) will be administered in a dose increasing mode:
the initial dose will be 500mg twice daily, which will be increased to 1000mg twice daily
after two weeks, and then maintained until the end of treatment in total 12 weeks.
Arm group label:
metformin
Other name:
Glucophage
Intervention type:
Drug
Intervention name:
Semaglutide, 1.34 mg/mL
Description:
Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of
day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to
0.5mg QW after 4 weeks, and increased to 1.0mg QW after another 4 weeks, and then
maintained 1.0mg until the end of treatment in total 12 weeks.
Arm group label:
semaglutide
Other name:
WEGOVY
Intervention type:
Drug
Intervention name:
Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG
Description:
Both Semaglutide injection and Metformin oral tablet will be administered as described
above.
Arm group label:
semaglutide and metformin
Other name:
WEGOVY and Glucophage
Intervention type:
Behavioral
Intervention name:
calorie-restricted diet
Description:
All subjects after randomization will be reviewed and evaluated by a nutritionist, and
then will receive diet guidance. The clinical nutritionist will develop a written
nutrition plan for each subject. The nutrition plan of this study adopted the method of
calorie restriction diet (CRD) to develop a diet, which required 83.68 kJ/kg of energy
per day, 1.2 g/kg of protein per day, 40%~55% of carbohydrate energy supply ratio, and
20%~30% of fat energy supply ratio, to ensure the intake of vegetables, fruits and other
rich dietary fiber, and drinking more than 1.5 L per day. The nutritionist will explain
the method of food exchange in detail to enrich the food types of patients. The diet
diary will be distributed to each subject, and the subjects will be required to make a
return visit once every four weeks, return the diet diary each time, and receive guidance
according to their compliance.
Arm group label:
metformin
Arm group label:
semaglutide
Arm group label:
semaglutide and metformin
Intervention type:
Behavioral
Intervention name:
physical exercise
Description:
All subjects after randomization will be reviewed and evaluated by a trainer, and then
will receive guidance of physical exercise.The trainer will formulate an exercise plan
for each subject. The exercise plan consists of 30 minutes of moderate and low intensity
continuous aerobic exercise every day, with a frequency of 5-7 days/week. The form of
exercise can be determined according to personal hobbies, such as fast walking, jogging,
climbing, swimming, etc. The exercise diary will be distributed to each subject, and the
subjects are required to make a return visit once every four weeks, return the exercise
diary each time, and the trainer will provide guidance to the subjects according to their
compliance.
Arm group label:
metformin
Arm group label:
semaglutide
Arm group label:
semaglutide and metformin
Summary:
To investigate the efficacy of semaglutide in obese infertile women of childbearing age
with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and
controlled study. 75 obese infertile PCOS patients will be recruited and randomized into
three groups: metformin, semaglutide and metformin+semaglutide, on the basis of
calorie-restricted diet and physical exercise. All subjects will be treated for 12 weeks,
and then stop taking the drug for at least 8 weeks to initiate ovulation induction or
ovulation induction combined with artificial insemination. All subjects will be followed
up for 24 weeks for pregnancy outcome. The primary endpoint of the study is the
percentage of weight loss at 12 weeks of treatment. The secondary endpoints include
HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of
follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression,
anxiety, diet and quality of life scores at 12 weeks of treatment.
Detailed description:
To investigate the efficacy of semaglutide in obese infertile women of childbearing age
with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and
controlled study. 75 obese infertile PCOS patients will be recruited and randomized into
three groups: metformin, semaglutide and metformin+semaglutide, on the basis of
calorie-restricted diet and physical exercise. Metformin and semaglutide will be
administered in a dose increasing mode, and then maintain until the end of 12 weeks, and
metabolic related indexes will be evaluated. After 12 weeks of treatment, all subjects
will stop taking the drug for at least 8 weeks to initiate ovulation induction or
ovulation induction combined with artificial insemination. All subjects will be followed
up for 24 weeks to evaluate the fertility related indicators. The primary endpoint of the
study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints
include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks
of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression,
anxiety, diet and quality of life scores at 12 weeks of treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Meet the PCOS diagnostic criteria (Rotterdam）
2. Age 22-40
3. BMI ≥ 28 kg/m2
4. Infertility: having normal sexual life and failing to conceive without contraception
for more than 1 year
5. Willing to be pregnant, and her husband has no serious infertility
Exclusion Criteria:
1. History of acute pancreatitis, individual or family history of medullary thyroid
cancer and multiple endocrine adenomas
2. Type 1 diabetes and special type diabetes
3. History of tumor
4. Serious cardiovascular and cerebrovascular disease, mental disease, liver or kidney
disease
5. Metformin, GLP-1 RA and other drugs affecting reproductive and metabolic functions
were used within 90 days before the study
6. Known allergy to metformin, GLP-1 RA and excipients
7. Severe endometriosis, low ovarian reserve, premature ovarian failure
8. Inability to tolerate pregnancy and ovulation induction therapy
9. Other conditions considered unsuitable for this study by researchers
Gender:
Female
Gender based:
Yes
Minimum age:
22 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
PekingUFH
Address:
City:
Peking
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Tingtiing Zhang, MD
Phone:
86-10-13691415781
Email:
cathine@sina.com
Start date:
May 9, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05702905
