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

Primary Purpose

Polycystic Ovary Syndrome, Infertility, ART

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
placebo
metformin
Sitagliptin
Sitagliptin/metformin
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring metformin, sitagliptin, Polycystic Ovary Syndrome, Intracytoplastic sperm injection

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mahdiyeh educational hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Metformin

Sitagliptin

sitagliptin/metformin

Arm Description

Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily

Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily

Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily

Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily

Outcomes

Primary Outcome Measures

Fasting insulin
ELIZA hormone assay
Growth differentiation factor-9(GDF-9) expression
Realtime PCR
Bone morphogenetic protein-15(BMP-15) expression
Realtime PCR
Total Testosterone
ELIZA hormone assay
Follicle-stimulating hormone(FSH)
ELIZA hormone assay

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
March 19, 2021
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04268563
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
July 19, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Infertility, ART
Keywords
metformin, sitagliptin, Polycystic Ovary Syndrome, Intracytoplastic sperm injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
Arm Title
Metformin
Arm Type
Experimental
Arm Description
Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily
Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily
Arm Title
sitagliptin/metformin
Arm Type
Experimental
Arm Description
Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
rehydration solution
Intervention Description
Oral rehydration solution
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
Glucophage
Intervention Description
metformin tablet
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
JANUVIA
Intervention Description
Sitagliptin tablet
Intervention Type
Drug
Intervention Name(s)
Sitagliptin/metformin
Other Intervention Name(s)
JANUMET
Intervention Description
Sitagliptin/metformin tablet
Primary Outcome Measure Information:
Title
Fasting insulin
Description
ELIZA hormone assay
Time Frame
24 hours after last dose
Title
Growth differentiation factor-9(GDF-9) expression
Description
Realtime PCR
Time Frame
24 hours after last dose
Title
Bone morphogenetic protein-15(BMP-15) expression
Description
Realtime PCR
Time Frame
24 hours after last dose
Title
Total Testosterone
Description
ELIZA hormone assay
Time Frame
24 hours after last dose
Title
Follicle-stimulating hormone(FSH)
Description
ELIZA hormone assay
Time Frame
24 hours after last dose

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study is based women with polycystic ovary syndrome.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Delbar Daneshjou, PHD student
Phone
989120823342
Email
db.daneshjou@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahrzad Shahrzad Zadehmodarres, Professor
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Mahdiyeh educational hospital
City
Tehran
ZIP/Postal Code
1989930002
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delbar Daneshjou, PHD student
Phone
989120823342
Email
db.daneshjou@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32720198
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.
Results Reference
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Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients

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