A Comparative Study on Therapeutic Effect of Sitagliptin-Metformin and Metformin in Infertile Women with polycystic ovary syndrome (PCOS) undergoing intra-cytoplasmic sperm injection (ICSI)

we will evaluate and compare the efficacy of Sitagliptin-Metformin, on PCOS patients undergoing intracytoplasmic sperm injection(ICSI).

a randomized clinical trial, placebo con- trolled pilot study

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 population randomly divide into four groups.The ovulation induction stimulate with GnRh antagonist

In this study, Infertility due to polycystic ovary syndrome at the age of 25 to 35 is considered as the inclusion criteria.. Hypersensitivity to either metformin or Sitagliptin or sitagliptin-metformin, presence of infertility factors other than anovulation, male infertility, pelvic organic pathologies, congenital adrenal hyperplasia, thyroid dysfunction, Cushing’s syndrome, hyperprolactinemia, androgen secreting neoplasia, diabetes mellitus, consumption of medications affecting carbohydrate metabolism, taking hormonal analogues other than progesterone two months prior to enrollment, and severe hepatic, Pancreatic or kidney diseases were considered as exclusion criteria.

Patients divide into 4 groups (n=20): group1: metformin (500 mg two times daily),group2: Sitagliptin (50 mg two times daily), gruop3: sitagliptin-metformin (50/500 mg two times daily) and group4: placebo two times daily.

Oocyte quality, embryo quality, metabolic and hormonal factors

Randomization was done from a computer-generated sequence, concealed in sequentially numbered, sealed, opaque envelopes

The tablets of sitagliptin, metformin, sitagliptin-metformin and placebo are placed in similar containers and given to patients by midwife. Also, the gynecologist is not aware of the type of treatment patients receive.

Data such as metabolic factors, number of eggs, and embryos will be available.

Access will start 12 months after printing.

The data will be available to researchers working in academic and scientific institutions.

The data will be made available for statistical analysis if all partners agree.

Delbar Danesshjou Email:D.daneshjou2yahoo.com Phone number: 00989120823342

Data should be extracted from patient records and made available about 2 month later.