Clinical trial NCT04268563: Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients
Official title: Comparing the Therapeutic Effect of Sitagliptin/Metformin and Metformin on Biochemical Factors and Expression of GDF-9 and BMP-15 Genes in Patients With Classic PCOS Undergoing Intra-cytoplasmic Sperm Injection (ICSI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovary Syndrome
Infertility
ART
Keywords: metformin
sitagliptin
Polycystic Ovary Syndrome
Intracytoplastic sperm injection
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting insulin
timeFrame: 24 hours after last dose
measure: Growth differentiation factor-9(GDF-9) expression
timeFrame: 24 hours after last dose
measure: Bone morphogenetic protein-15(BMP-15) expression
timeFrame: 24 hours after last dose
measure: Total Testosterone
timeFrame: 24 hours after last dose
measure: Follicle-stimulating hormone(FSH)
timeFrame: 24 hours after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mahdiyeh educational hospital
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Shahrzad Shahrzad Zadehmodarres, Professor
role: STUDY_DIRECTOR
References:
citation: Daneshjou D, Zadeh Modarres S, Soleimani Mehranjani M, Shariat Zadeh SMA. Comparing the effect of sitagliptin and metformin on the oocyte and embryo quality in classic PCOS patients undergoing ICSI. Ir J Med Sci. 2021 May;190(2):685-692. doi: 10.1007/s11845-020-02320-5. Epub 2020 Jul 28.