NCT04268563

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

January 28, 2020

Last Update Submit

March 19, 2021

Conditions

Polycystic Ovary SyndromeInfertilityART

Keywords

metforminsitagliptinPolycystic Ovary SyndromeIntracytoplastic sperm injection

Outcome Measures

Primary Outcomes (5)

  • Fasting insulin

    ELIZA hormone assay

    24 hours after last dose

  • Growth differentiation factor-9(GDF-9) expression

    Realtime PCR

    24 hours after last dose

  • Bone morphogenetic protein-15(BMP-15) expression

    Realtime PCR

    24 hours after last dose

  • Total Testosterone

    ELIZA hormone assay

    24 hours after last dose

  • Follicle-stimulating hormone(FSH)

    ELIZA hormone assay

    24 hours after last dose

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Metformin

EXPERIMENTAL

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

Drug: metformin

Sitagliptin

EXPERIMENTAL

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

Drug: Sitagliptin

sitagliptin/metformin

EXPERIMENTAL

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

Drug: Sitagliptin/metformin

Interventions

placeboDRUG

Oral rehydration solution

Also known as: rehydration solution
Placebo
metforminDRUG

metformin tablet

Also known as: Glucophage
Metformin
SitagliptinDRUG

Sitagliptin tablet

Also known as: JANUVIA
Sitagliptin
Sitagliptin/metforminDRUG

Sitagliptin/metformin tablet

Also known as: JANUMET
sitagliptin/metformin

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy is based women with polycystic ovary syndrome.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • subject has clinical or biochemical hyperandrogenic symptoms
  • subject has oligo/amenorrhea cycles

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahdiyeh educational hospital

Tehran, 1989930002, Iran

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32720198DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Interventions

Rehydration SolutionsMetforminSitagliptin PhosphateSitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SolutionsPharmaceutical PreparationsBiguanidesGuanidinesAmidinesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesDrug Combinations

Study Officials

  • Shahrzad Shahrzad Zadehmodarres, Professor

    Shahid Beheshti University of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Delbar Daneshjou, PHD student

CONTACT

989120823342db.daneshjou@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2020

First Posted

February 13, 2020

Study Start

January 10, 2020

Primary Completion

July 19, 2021

Study Completion

July 30, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations

IR(1)