Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients

Infertility Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04268563
• Other study ID #: 11367
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 10, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2021
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Delbar Daneshjou, PHD student
• Phone: 989120823342
• Email: db.daneshjou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 30, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• ART
• Infertility
• Polycystic Ovary Syndrome

Intervention

Drug:
• placebo
Oral rehydration solution
• metformin
metformin tablet
• Sitagliptin
Sitagliptin tablet
• Sitagliptin/metformin
Sitagliptin/metformin tablet

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mahdiyeh educational hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting insulin	ELIZA hormone assay	24 hours after last dose
Primary	Growth differentiation factor-9(GDF-9) expression	Realtime PCR	24 hours after last dose
Primary	Bone morphogenetic protein-15(BMP-15) expression	Realtime PCR	24 hours after last dose
Primary	Total Testosterone	ELIZA hormone assay	24 hours after last dose
Primary	Follicle-stimulating hormone(FSH)	ELIZA hormone assay	24 hours after last dose