Polycystic Ovarian SyndromeNCT06587698
Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
A study testing Sitagliptin, BeiDouGen and Sitagliptin+BeiDouGen in people with Polycystic Ovarian Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study will be carried out under the guidance of professional doctor, patients with PCOS will be treated with Sitagliptin or BeiDouGen capsule or both two to assess their ovarian function and reproductive outcomes, and compare the effect of different treatment methods, which will provide the basis for PCOS… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- Sitagliptin, BeiDouGen and Sitagliptin+BeiDouGen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 20-40 years who plan to conceive or are infertile in our center.
- Diagnosed with PCOS according to the Rotterdam criteria: Diagnosis of PCOS can be made if two out of the following three criteria are met: (1) Oligoovulation or anovulation, (2) Clinical or biochemical signs of hyperandrogenism, (3) Polycystic ovaries on ultrasound examination.
- Patients who are regularly followed up at our clinic. No participation in other research projects currently or in the past 3 months.
Who cannot join
- Exclusion criteria (any of the following criteria met will result in exclusion):
- Pregnant, lactating, or postmenopausal women. Taking weight loss medications or undergoing weight loss surgery in the past 3 months or currently.
- Food allergies. Other diseases that may cause hyperandrogenism or ovulation abnormalities (e.g., Cushing's syndrome, non-classical congenital adrenal hyperplasia, tumors secreting androgens in the ovaries or adrenal glands, functional hypothalamic amenorrhea, thyroid diseases, hyperprolactinemia, premature ovarian insufficiency, etc.).
- Use of insulin, hypoglycemic drugs, or beta-blockers in the past 3 months. Patients with chronic diseases such as hypertension, gout, hyperuricemia, diabetes, etc., requiring regular medication.
- Use of glucocorticoids, anti-androgenic drugs, oral contraceptives, ovulation-inducing drugs, weight loss drugs, or other medications affecting hormone levels, appetite, and carbohydrate metabolism in the past 2 months.
- Patients with liver cirrhosis or various severe liver diseases (alanine aminotransferase and/or aspartate aminotransferase exceeding 3 times the upper limit of normal), patients with abnormal renal function (serum creatinine exceeding the upper limit of normal), patients with kidney disease or other diseases requiring control of protein intake.
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- Patients currently or previously with severe cardiovascular and cerebrovascular diseases that may interfere with the normal conduct of the trial (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmias, patients undergoing interventional therapy, etc.).
- Patients currently with severe gastrointestinal diseases such as gastrointestinal ulcer bleeding, chronic diarrhea, or who have undergone gastrointestinal resection surgery, which may affect nutrient absorption.
- Patients with infectious diseases such as hepatitis B e antigen-positive, active pulmonary tuberculosis, or HIV.
- Cancer patients or those who have received radiation and chemotherapy within the past five years.
- Patients with any psychological or psychiatric disorders requiring medication, including epilepsy patients or those undergoing antiepileptic treatment, patients using antidepressants, etc.
- Daily alcohol consumption exceeding 15g. Smoking habit
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Jie Qiao, 010-82265080, jie.qiao@263.net
About this study
This study will be carried out under the guidance of professional doctor, patients with PCOS will be treated with Sitagliptin or BeiDouGen capsule or both two to assess their ovarian function and reproductive outcomes, and compare the effect of different treatment methods, which will provide the basis for PCOS intervention strategy and related research
Read the detailed description
Subject Recruitment and Grouping This study adopts an open-label randomized controlled trial design. We plan to recruit a total of 300 patients with polycystic ovary syndrome (PCOS) by introducing the purpose, benefits, and risks of the study to patients in medical or examination units. PCOS patients who meet the inclusion criteria and do not meet the exclusion criteria will be registered and given a questionnaire by the research staff after signing the informed consent form. Physical and blood examinations will be conducted, and electronic randomization will be performed using the Redcap platform.
Intervention Measures After signing the informed consent form, enrolled patients will be randomly assigned to the Sitagliptin intervention group, the Bei Dou Gen intervention group, or the combination therapy group of Sitagliptin and Bei Dou Gen. Before enrollment, all three groups will undergo baseline assessments including blood routine, liver and kidney function, blood lipids, endocrine hormones, gynecological ultrasound, liver ultrasound, and physical examinations.
For participants in the Sitagliptin intervention group, Sitagliptin will be administered orally at a dose of 100 mg once daily for a treatment period of three months. Participants in the Bei Dou Gen intervention group will receive Bei Dou Gen capsules orally at a dose of 60 mg twice daily for a treatment period of three months. Participants in the combination therapy group will receive both Sitagliptin at a dose of 100 mg once daily and Bei Dou Gen capsules at a dose of 60 mg twice daily for a treatment period of three months.
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- Sitagliptin, BeiDouGen, Sitagliptin+BeiDouGen
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called brand name:Jie Nuo Wei
100 mg QD for 3 month
BeiDouGenDrug
Also called brand name:Kang xin
60 mg BID for 3 month
Sitagliptin+BeiDouGenDrug
Also called brand name:Jie Nuo Wei and Kang xin
100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Other | 100mg/day Sitagliptin by oral for 3 months
detail：1 piece(100mg) at morning Receives: Drug: Sitagliptin |
| BeiDouGen | Other | 120mg/day BeiDouGen capsule by oral for 3 months
detail：2 piece(30mg) at morning and night Receives: Drug: BeiDouGen |
| Sitagliptin+BeiDouGen | Other | 100mg/day Sitagliptin+120mg/day BeiDouGen capsule by oral for 3 months
detail：1 piece(100mg) Sitagliptin and 2 piece(30mg) BeiDouGen capsule at morning 2 piece(30mg) BeiDouGen capsule at night Receives: Drug: Sitagliptin+BeiDouGen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
the pregnancy situation among volunteers
Measured: through study completion, an average of 2 year
Secondary outcomes (15)
DHEA
dehydroepiandrosteron in serum during menstruation period
Measured: before and after intervention（3 month）
total testosterone
total testosterone in serum during menstruation period
Measured: before and after intervention（3 month）
FAI
Free testosterone index calculated by total testosterone and SHBG
Measured: before and after intervention（3 month）
LH/FSH
the rate between LH and FSH
Measured: before and after intervention（3 month）
ovarian volume
the size is measured by ultrasound
Measured: before and after intervention（3 month）
number of antral follicles
the number is is measured by ultrasound during menstruation period
Measured: before and after intervention（3 month）
Number of retrieved eggs
the number is observed during the surgery
Measured: after intervention（3 month）
number of mature eggs (MII)
observed the state of oocytes during the IVF laboratory
Measured: after intervention（3 month）
fertilization rate
observed the state of oocytes during the IVF laboratory
Measured: after intervention（3 month）
number of usable embryos,
observed the state of embryos during the IVF laboratory
Measured: after intervention（3 month）
number of high-quality embryos
observed the state of embryos during the IVF laboratory
Measured: after intervention（3 month）
GLP-1 levels
measure it in the serum
Measured: before and after intervention（3 month）
fasting glucose
measured by glucometer
Measured: before and after intervention（3 month）
OGTT
measured by glucometer
Measured: before and after intervention（3 month）
HOMA index
calculated by glucose and INS
Measured: before and after intervention（3 month）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Aug 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Qiao, Study chair, the third hospital of peking universry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587698
- Sponsor's protocol ID
- M2024342
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
- ClinicalTrials.gov ID
- NCT06587698
- Acronym / sponsor ID
- M2024342
- Conditions
- Polycystic Ovarian Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 19 Sep 2024 (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.
This study will be carried out under the guidance of professional doctor, patients with PCOS will be treated with Sitagliptin or BeiDouGen capsule or both two to assess their ovarian function and reproductive outcomes, and compare the effect of different treatment methods, which will provide the basis for PCOS intervention strategy and related research
Detailed description
Subject Recruitment and Grouping This study adopts an open-label randomized controlled trial design. We plan to recruit a total of 300 patients with polycystic ovary syndrome (PCOS) by introducing the purpose, benefits, and risks of the study to patients in medical or examination units. PCOS patients who meet the inclusion criteria and do not meet the exclusion criteria will be registered and given a questionnaire by the research staff after signing the informed consent form. Physical and blood examinations will be conducted, and electronic randomization will be performed using the Redcap platform.
Intervention Measures After signing the informed consent form, enrolled patients will be randomly assigned to the Sitagliptin intervention group, the Bei Dou Gen intervention group, or the combination therapy group of Sitagliptin and Bei Dou Gen. Before enrollment, all three groups will undergo baseline assessments including blood routine, liver and kidney function, blood lipids, endocrine hormones, gynecological ultrasound, liver ultrasound, and physical examinations.
For participants in the Sitagliptin intervention group, Sitagliptin will be administered orally at a dose of 100 mg once daily for a treatment period of three months. Participants in the Bei Dou Gen intervention group will receive Bei Dou Gen capsules orally at a dose of 60 mg twice daily for a treatment period of three months. Participants in the combination therapy group will receive both Sitagliptin at a dose of 100 mg once daily and Bei Dou Gen capsules at a dose of 60 mg twice daily for a treatment period of three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Other | Drug: Sitagliptin100mg/day Sitagliptin by oral for 3 months detail：1 piece(100mg) at morning |
| BeiDouGen | Other | Drug: BeiDouGen120mg/day BeiDouGen capsule by oral for 3 months detail：2 piece(30mg) at morning and night |
| Sitagliptin+BeiDouGen | Other | Drug: Sitagliptin+BeiDouGen100mg/day Sitagliptin+120mg/day BeiDouGen capsule by oral for 3 months detail：1 piece(100mg) Sitagliptin and 2 piece(30mg) BeiDouGen capsule at morning 2 piece(30mg) BeiDouGen capsule at night |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients aged 20-40 years who plan to conceive or are infertile in our center.
- Diagnosed with PCOS according to the Rotterdam criteria: Diagnosis of PCOS can be made if two out of the following three criteria are met: (1) Oligoovulation or anovulation, (2) Clinical or biochemical signs of hyperandrogenism, (3) Polycystic ovaries on ultrasound examination.
- Patients who are regularly followed up at our clinic. No participation in other research projects currently or in the past 3 months.
Key exclusion criteria (13 listed)
- Pregnant, lactating, or postmenopausal women. Taking weight loss medications or undergoing weight loss surgery in the past 3 months or currently.
- Food allergies. Other diseases that may cause hyperandrogenism or ovulation abnormalities (e.g., Cushing's syndrome, non-classical congenital adrenal hyperplasia, tumors secreting androgens in the ovaries or adrenal glands, functional hypothalamic amenorrhea, thyroid diseases, hyperprolactinemia, premature ovarian insufficiency, etc.).
- Use of insulin, hypoglycemic drugs, or beta-blockers in the past 3 months. Patients with chronic diseases such as hypertension, gout, hyperuricemia, diabetes, etc., requiring regular medication.
- Use of glucocorticoids, anti-androgenic drugs, oral contraceptives, ovulation-inducing drugs, weight loss drugs, or other medications affecting hormone levels, appetite, and carbohydrate metabolism in the past 2 months.
- Patients with liver cirrhosis or various severe liver diseases (alanine aminotransferase and/or aspartate aminotransferase exceeding 3 times the upper limit of normal), patients with abnormal renal function (serum creatinine exceeding the upper limit of normal), patients with kidney disease or other diseases requiring control of protein intake.
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 |
|---|---|---|
| SitagliptinAlso: brand name:Jie Nuo Wei100 mg QD for 3 month | Drug | Sitagliptin |
| BeiDouGenAlso: brand name:Kang xin60 mg BID for 3 month | Drug | BeiDouGen |
| Sitagliptin+BeiDouGenAlso: brand name:Jie Nuo Wei and Kang xin100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month | Drug | Sitagliptin+BeiDouGen |
Primary outcome
Clinical pregnancy rate
Time frame: through study completion, an average of 2 year
the pregnancy situation among volunteers
15 secondary outcomes
DHEA
Time frame: before and after intervention（3 month）
total testosterone
Time frame: before and after intervention（3 month）
FAI
Time frame: before and after intervention（3 month）
LH/FSH
Time frame: before and after intervention（3 month）
ovarian volume
Time frame: before and after intervention（3 month）
number of antral follicles
Time frame: before and after intervention（3 month）
Number of retrieved eggs
Time frame: after intervention（3 month）
number of mature eggs (MII)
Time frame: after intervention（3 month）
fertilization rate
Time frame: after intervention（3 month）
number of usable embryos,
Time frame: after intervention（3 month）
number of high-quality embryos
Time frame: after intervention（3 month）
GLP-1 levels
Time frame: before and after intervention（3 month）
fasting glucose
Time frame: before and after intervention（3 month）
OGTT
Time frame: before and after intervention（3 month）
HOMA index
Time frame: before and after intervention（3 month）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Jie Qiao study chair
the third hospital of peking universry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitagliptin, BeiDouGen and Sitagliptin+BeiDouGen in people with Polycystic Ovarian Syndrome, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Qiao, PhD (15611555481, myl1995lmy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.