Polycystic Ovary SyndromePhase 1/2NCT04268563
Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients
A Phase 1/2 study testing metformin, Sitagliptin and Sitagliptin/metformin in people with Polycystic Ovary Syndrome and Infertility, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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). Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility, ART
- What is being tested?
- metformin, Sitagliptin and Sitagliptin/metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 10 Jan 2020to 30 Jul 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- subject has clinical or biochemical hyperandrogenic symptoms
- subject has oligo/amenorrhea cycles
Who cannot join
- Hypersensitivity to metformin
- Hypersensitivity to sitagliptin presence of infertility factors other than anovulation,
- male infertility
- pelvic organic pathologies
- congenital adrenal hyperplasia
- thyroid dysfunction
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mahdiyeh educational hospital
Tehran, 1989930002
Delbar Daneshjou, PHD student, 989120823342, db.daneshjou@gmail.com
About this study
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)
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).
Read the 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.
- Conditions
- Polycystic Ovary Syndrome, Infertility, ART
- Being tested
- placebo, metformin, Sitagliptin, Sitagliptin/metformin
- Keywords
- metformin, sitagliptin, Polycystic Ovary Syndrome, Intracytoplastic sperm injection
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called rehydration solution
Oral rehydration solution
metforminDrug
Also called Glucophage
metformin tablet
SitagliptinDrug
Also called JANUVIA
Sitagliptin tablet
Sitagliptin/metforminDrug
Also called JANUMET
Sitagliptin/metformin tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily Receives: Drug: placebo |
| Metformin | Experimental | Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily Receives: Drug: metformin |
| Sitagliptin | Experimental | Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily Receives: Drug: Sitagliptin |
| sitagliptin/metformin | Experimental | Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily Receives: Drug: Sitagliptin/metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting insulin
ELIZA hormone assay
Measured: 24 hours after last dose
Growth differentiation factor-9(GDF-9) expression
Realtime PCR
Measured: 24 hours after last dose
Bone morphogenetic protein-15(BMP-15) expression
Realtime PCR
Measured: 24 hours after last dose
Total Testosterone
ELIZA hormone assay
Measured: 24 hours after last dose
Follicle-stimulating hormone(FSH)
ELIZA hormone assay
Measured: 24 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start10 Jan 2020
- Primary completion19 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Delbar Daneshjou, Shahid Beheshti University of Medical Sciences
- Investigators
- Shahrzad Shahrzad Zadehmodarres, Professor, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268563
- Sponsor's protocol ID
- 11367
- Status last verified
- Mar 2021
- First submitted
- 28 Jan 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32720198
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04268563
- Acronym / sponsor ID
- 11367
- Conditions
- Polycystic Ovary Syndrome, Infertility, ART
- Keywords
- metformin, sitagliptin, Polycystic Ovary Syndrome, Intracytoplastic sperm injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 19 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboControl group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily |
| Metformin | Experimental | Drug: metforminIntervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily |
| Sitagliptin | Experimental | Drug: SitagliptinIntervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily |
| sitagliptin/metformin | Experimental | Drug: Sitagliptin/metforminIntervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- subject has clinical or biochemical hyperandrogenic symptoms
- subject has oligo/amenorrhea cycles
Key exclusion criteria (16 listed)
- Hypersensitivity to metformin
- Hypersensitivity to sitagliptin presence of infertility factors other than anovulation,
- male infertility
- pelvic organic pathologies
- congenital adrenal hyperplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: rehydration solutionOral rehydration solution | Drug | Placebo |
| metforminAlso: Glucophagemetformin tablet | Drug | Metformin |
| SitagliptinAlso: JANUVIASitagliptin tablet | Drug | Sitagliptin |
| Sitagliptin/metforminAlso: JANUMETSitagliptin/metformin tablet | Drug | sitagliptin/metformin |
Primary outcome
Fasting insulin
Time frame: 24 hours after last dose
ELIZA hormone assay
Growth differentiation factor-9(GDF-9) expression
Time frame: 24 hours after last dose
Realtime PCR
Bone morphogenetic protein-15(BMP-15) expression
Time frame: 24 hours after last dose
Realtime PCR
Total Testosterone
Time frame: 24 hours after last dose
ELIZA hormone assay
Follicle-stimulating hormone(FSH)
Time frame: 24 hours after last dose
ELIZA hormone assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Derived from this study: PubMed 32720198Daneshjou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahrzad Shahrzad Zadehmodarres, Professor study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing metformin, Sitagliptin and Sitagliptin/metformin in people with Polycystic Ovary Syndrome and Infertility, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delbar Daneshjou, PHD student (989120823342, db.daneshjou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting insulin (time frame: 24 hours after last dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04268563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.