NCT04268563 is a Phase 1, PHASE2 clinical trial of metformin in Polycystic Ovary Syndrome, sponsored by Shahid Beheshti University of Medical Sciences.

Who is sponsoring NCT04268563?

NCT04268563 is sponsored by Shahid Beheshti University of Medical Sciences.

What drugs are being tested in NCT04268563?

Interventions in NCT04268563: placebo, metformin, Sitagliptin, Sitagliptin/metformin.

What condition does NCT04268563 study?

NCT04268563 studies Polycystic Ovary Syndrome, Infertility, ART.

Is NCT04268563 still recruiting?

NCT04268563 is currently status unknown. Last updated 22 March 2021.

Last reviewed 2021-03-22 · How we verify

NCT04268563

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1, PHASE2 Last updated 22 March 2021

What this trial tests

Phase 1, PHASE2 trial testing placebo in Polycystic Ovary Syndrome in 80 participants. Status unknown.

Timeline

10 January 2020

Primary endpoint
19 July 2021

30 July 2021

Quick facts

Lead sponsor	Shahid Beheshti University of Medical Sciences
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	10 January 2020
Primary completion	19 July 2021
Estimated completion	30 July 2021
Sites	1 location across Iran

Drugs / interventions tested

placebo
metformin (metformin) — full drug profile →
Sitagliptin (SITAGLIPTIN) — full drug profile →
Sitagliptin/metformin

Conditions studied

Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
Infertility — all drugs for Infertility →
ART — all drugs for ART →

Sponsor

Shahid Beheshti University of Medical Sciences

Who can join

Adults 25 to 35, female only, with Polycystic Ovary Syndrome or Infertility. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Comparing the effect of sitagliptin and metformin on the oocyte and embryo quality in classic PCOS patients undergoing ICSI.
Daneshjou D, Zadeh Modarres S, Soleimani Mehranjani M, Shariat Zadeh SMA. · · 2021 · cited 7× · PMID 32720198 · DOI 10.1007/s11845-020-02320-5
Comparative evaluation of metformin & sitaformin in classic PCOS patients undergoing intracytoplasmic sperm injection: A randomized controlled pilot study.
Modarres SZ, Daneshjou D, Mehranjani MS, Ali Shariatzadeh SM. · · 2023 · cited 3× · PMID 37040229 · DOI 10.4103/ijmr.ijmr_2139_20
Beyond glycemic control: molecular mechanisms of metformin in modulating cytokine networks in polycystic ovary syndrome.
Ullah A, Chen Y, Zhang F, Shen B. · · 2026 · PMID 41737049 · DOI 10.3389/fendo.2026.1749906

Verify or expand the search:

Other trials of metformin

Trials testing the same drug.

NCT06463743 — Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS) · Phase 2 · recruiting
NCT06679413 — A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants · Phase 1 · completed
NCT05966792 — SGLT2 Inhibitors in Treating Patients With PCOS · NA · completed
NCT05767515 — The Effects of Acetyl-L-Carnitine and Myo/Chiro-Inositol in Patients With PCOS · NA · completed
NCT05815680 — A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overw · Phase 1 · completed

Other recruiting trials for Polycystic Ovary Syndrome

Currently open trials in the same condition.

NCT07591246 — Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction · NA · recruiting
NCT07446985 — Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma? · NA · recruiting
NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting

Other Shahid Beheshti University of Medical Sciences trials

Trials by the same sponsor.

NCT07005687 — Using MSCs for Chronic Active Antibody Mediated Rejection · NA · not yet recruiting
NCT07435558 — Homogeneous vs. Heterogeneous Learning Style Grouping in Problem-Based Learning Among Nurses · NA · not yet recruiting
NCT07408492 — Impact of AI-Based Research Training on Nursing Students · NA · not yet recruiting
NCT07176663 — Efficacy and Safety of Tirzepatide (Spartina) in Chronic Kidney Failure · NA · not yet recruiting
NCT07291622 — Synchrony-Optimized Non-Invasive Ventilation Education Program and ICU Patients · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04268563 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shahid Beheshti University of Medical Sciences
Last refreshed: 22 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04268563.

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