Polycystic Ovary Syndrome, Infertility, ART
Conditions
Keywords
metformin, sitagliptin, Polycystic Ovary Syndrome, Intracytoplastic sperm injection
Brief summary
Investigators will evaluate and compare the efficacy of Sitagliptin/Metformin to metformin and sitagliptin on gdf9 and bmp15 gene expression on PCOS patients undergoing intracytoplasmic sperm injection(ICSI).
Detailed description
This study was conducted in Infertility clinic of Mahdiyeh Educational Hospital, Tehran. Patients in the four groups receive the drug 2 months before the start of the ovulation cycle, and treatment will continue until the day of the oocyte aspiration. The drug provide by midwife to patients and both patient and physician blind to the treatment regimen. The participants randomly divide into four groups.The ovulation induction stimulate with GnRh antagonist.
Interventions
DRUGplacebo
Oral rehydration solution
DRUGmetformin
metformin tablet
DRUGSitagliptin
Sitagliptin tablet
Sitagliptin/metformin tablet
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* subject has clinical or biochemical hyperandrogenic symptoms * subject has oligo/amenorrhea cycles
Exclusion criteria
* Hypersensitivity to metformin * Hypersensitivity to sitagliptin presence of infertility factors other than anovulation, * male infertility * pelvic organic pathologies * congenital adrenal hyperplasia * thyroid dysfunction * Cushing's syndrome * hyper prolactinemia * androgen secreting neoplasia * diabetes mellitus * consumption of medications affecting carbohydrate metabolism * consumption hormonal analogues other than progesterone 2 months prior to enrolment in the study * severe hepatic * pancreatitis * kidney diseases * gallbladder diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting insulin | 24 hours after last dose | ELIZA hormone assay |
| Growth differentiation factor-9(GDF-9) expression | 24 hours after last dose | Realtime PCR |
| Bone morphogenetic protein-15(BMP-15) expression | 24 hours after last dose | Realtime PCR |
| Total Testosterone | 24 hours after last dose | ELIZA hormone assay |
| Follicle-stimulating hormone(FSH) | 24 hours after last dose | ELIZA hormone assay |
Countries
Iran
Contacts
Primary ContactDelbar Daneshjou, PHD student
Outcome results
None listed