Clinical trial · Interventional
Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients
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)
NCT04268563CI-TRIAL-00050818unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ART | — | UNRESOLVED | — |
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin | Drug | Metformin | ALIAS |
| placebo | Drug | — | UNRESOLVED |
| Sitagliptin | Drug | — | UNRESOLVED |
| Sitagliptin/metformin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
- interventionNames
- Drug: placebo
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily
- interventionNames
- Drug: metformin
- type
- EXPERIMENTAL
- label
- Sitagliptin
- description
- Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDaneshjou 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 32720198