Polycystic Ovary Syndrome, Obesity, Infertility, Female
Conditions
Brief summary
The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.
Detailed description
Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.
Interventions
DRUGGLP-1 receptor agonist
3 months
DRUGMetformin
3 months
BEHAVIORALhealthy lifestyle education
3 months
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Women with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI\<35kg/m2;
Exclusion criteria
Women with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (\>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneous resumption of ovulation | 3 months |
| Clinical pregnancy | 9 months |
| Ongoing pregnancy | 11 months |
| Pregnancy loss | 18 months |
| Gestational age at delivery | 18 months |
| BMI change from baseline to the 3rd month in kg/m2 | 3 months |
| Hypertensive disorders of pregnancy | 18 months |
| Gestational diabetes | 18 months |
| Birth weight in kg | 18 months |
| Neonatal mortality | 18 months |
| Major congenital anomaly | 18 months |
| Time to pregnancy leading to live birth | 18 months |
Countries
China
Contacts
Primary ContactShuo Huang
Outcome results
None listed