Polycystic Ovary SyndromeEarly Phase 1NCT06601452
Clinical Trial of Anovulatory Infertility
A Early Phase 1 study testing a compound prescription of Chinese medicine in people with Polycystic Ovary Syndrome and Diminished Ovarian Reserve, run by Affiliated Hospital of Nanjing University of Chinese Medicine at 1 site in China.
Trial summary
This project aims to study the expression of clock genes and related proteins in follicular fluid and granulosa cells, depicting the periodic, amplitude, and phase changes of biological clock genes and related proteins in women of different ages during the reproductive period and in patients with ovulatory disorders. Read more about this study
- Who is it for?
- Ages 20 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Diminished Ovarian Reserve, Ovulation Disorder
- What is being tested?
- a compound prescription of Chinese medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 31 Dec 2028
- Phase
- Early Phase 1
- 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 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) meet the diagnostic criteria of infertility; 2) aged between 28 and 34 years old; 3) meet the diagnostic criteria of PCOS or DOR and the Chinese medicine diagnosis is kidney deficiency, or the ovarian function is normal in the case of IVF fertilization due to the male factor; 4) assisted in fertilization with IVF-ET antagonist or microstimulation; 5) the patients can tolerate the relevant treatment of the present study, and the compliance is good; 6) they have not used any medication before the treatment and have signed the informed consent. 7) Patients who have not used any medication before the treatment and have signed the informed consent for enrollment.
Who cannot join
- 1) Age > 35 years old; 2) Body mass index (BMI) ≥ 25kg/m2; 3) Abnormal karyotype of either spouse; 4) Uterine infertility, such as endometrial polyps, uterine adhesions, submucosal fibroids, adenomyosis, congenital uterine anomalies, etc.; 5) Endometriosis; 6) Repeated abortion; 7) Untreated hydrosalpinx; 8) Those who had used endocrine-affecting drugs in the last three months; 9) Combination of other contraindications to assisted reproduction techniques for conception such as psychiatric disorders, severely impaired liver or kidney function, thrombotic disorders, and malignant tumors.10) Those who were unable to give full informed consent due to intellectual or behavioral disabilities.11) Suspected or confirmed history of alcohol or drug abuse.12) According to the investigator's judgment (12) Other medical conditions that, in the judgment of the investigator, reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment that may result in loss of visits.13) Allergy, such as a history of allergy to two or more medications or foods, or a known allergy to the components of the medication.14) Patients participating in a clinical trial of another medication.
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
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210000
About this study
Official title: Exploring the Biological Basis of Tonifying the Kidney and Regulating the Menstrual Cycle in the Treatment of Anovulatory Infertility Based on the Circadian Rhythm of the Biological Clock
This project aims to study the expression of clock genes and related proteins in follicular fluid and granulosa cells, depicting the periodic, amplitude, and phase changes of biological clock genes and related proteins in women of different ages during the reproductive period and in patients with ovulatory disorders. The study compares the periodicity, amplitude, and phase changes of Clock/Bmal1-TTFLs-klotho related proteins and genes in PCOS, DOR patients, and age-matched women with normal ovarian function, aiming to identify the key segments of ovarian clock gene period rhythm disorder under different disease states, and screen the key time points of clock gene oscillation abnormality. Omics analysis of the differences between groups, analysis of the relationship between gene transcription translation, protein expression, metabolites, and the expression of clock genes, and deduction of the dynamic changes and interaction relationships of the biological processes within the ovaries in regulating ovulatory disorders using the method of reinforcing the kidney and regulating the menstrual cycle. This aims to clarify that maintaining the ovarian biological clock period rhythm is an important biological basis for "the kidney dominating reproduction". The regulation mechanism of the treatment of ovulatory disorders using the method of reinforcing the kidney and regulating the menstrual cycle is explained from the perspective of the ovarian biological clock period rhythm.
- Being tested
- a compound prescription of Chinese medicine
- 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.
a compound prescription of Chinese medicineDrug
The enrolled patients were treated with 3 cycles of sequential treatment with Nourishing Yin and Replenishing Yang formula before entering the cycle (Tuning Weekly Nourishing Yin Granules + Tuning Weekly Replenishing Yang Granules), and the egg retrieval cycle used an antagonist regimen to obtain the eggs.
| Study group | Role | What they receive |
|---|---|---|
| Chinese medicine treatment group（PCOS） | Experimental | Beginning on day 5 of the menstrual cycle, the treatment group was treated with a combination of Zi Yin and Yang Formula sequential treatment based on the control group, and Zi Yin and Yang Formula sequential treatment (Tuning Zhou Zi Yin Granules + Tuning Zhou and Yang Granules) was used in the 3 menstrual cycles prior to the IVF advancement week. Starting on the 5th day of the menstrual cycle, take the Tuning Zhou Zi Yin Granules (in-hospital preparation) orally. 2 packets each time, 3 times a day, 14 days of treatment; regulating Zhou Zhi Yin Granules (hospital preparation development), oral. Take 2 sachets each time, 3 times a day for 14 days. Receives: Drug: a compound prescription of Chinese medicine |
| Chinese medicine treatment group（DOR） | Experimental | Beginning on day 5 of the menstrual cycle, the treatment group was treated with a combination of Zi Yin and Yang Formula sequential treatment based on the control group, and Zi Yin and Yang Formula sequential treatment (Tuning Zhou Zi Yin Granules + Tuning Zhou and Yang Granules) was used in the 3 menstrual cycles prior to the IVF advancement week. Starting on the 5th day of the menstrual cycle, take the Tuning Zhou Zi Yin Granules (in-hospital preparation) orally. 2 packets each time, 3 times a day, 14 days of treatment; regulating Zhou Zhi Yin Granules (hospital preparation development), oral. Take 2 sachets each time, 3 times a day for 14 days. Receives: Drug: a compound prescription of Chinese medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human data
Serum indicators: Serum was collected on the 3rd and 21st day of the menstrual cycle before entering the treatment cycle, and ELISA was performed to detect changes in the amount of Bmal1, Clock, klotho, Per1, Per2, Per3, Cry1, Cry2, AMH, INHB, and sex hormones (E2, FSH, LH, P, and T) in the serum.
(2) Follicular fluid index: follicular fluid was retained on the day of ovulation, and changes in the concentration of Bmal1, Clock, klotho, AMH, INHB, and sex hormones (E2, FSH, LH, P, and T) in the follicular fluid were detected by ELISA.
(3) Granulosa cell indexes: Ovarian granulosa cells were cultured in vitro for 24 hours on the day of egg collection, and changes in mRNA and protein of the ovarian clock genes Bmal1, Clock, klotho, Per1, Per2, Per3, Cry1 and Cry2 were detected by qPCR and WB at 3-hour intervals.
(4) Histological indicators: follicular fluid and ovarian granulosa cells were retained on the day of egg collection for UPLC-Q-TOF/MS metabolomics, whole genome microarray genom
Measured: Main symptoms and signs: first day of the initial consultation, the third day of the menstrual cycle without entering the treatment cycle, the day of egg collection, and 14 days after the FET are each observed and recorded once.
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 start30 Sep 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- (i) Types of trial design: Multicentre, prospective, cross-sectional study; multicentre, prospective, double-blind, randomised controlled trial. (II) Principles of trial design 1. Number of cases: A total of 650 cases were included in the study, including 300 healthy women of reproductive age (divided into three groups according to age: 21-27 years old, 28-34 years old, 35-41 years old, 100 cases in each group), 150 cases of women with normal ovarian function who underwent in vitro fertilization-embryo transplantation (IVF-ET) due to male factor (divided into three groups according to age: 21-27 years old, 28-34 years old, 35-41 years old, 100 cases in each group). 34 years old, 35-41 years old, 50 cases in each group), 100 cases of PCOS infertility, 100 cases of DOR infertility. 2. Random control: According to the accepted principles of validity, safety and comparability, SPSS 27 statistical software, define the random seed number '20240001', according to 1:1 to generate the random se
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nanjing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601452
- Sponsor's protocol ID
- 2024NL-111-02
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Biological Basis of Tonifying the Kidney and Regulating the Menstrual Cycle in the Treatment of Anovulatory Infertility Based on the Circadian Rhythm of the Biological Clock
- ClinicalTrials.gov ID
- NCT06601452
- Acronym / sponsor ID
- 2024NL-111-02
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nanjing University of Chinese MedicineUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (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 project aims to study the expression of clock genes and related proteins in follicular fluid and granulosa cells, depicting the periodic, amplitude, and phase changes of biological clock genes and related proteins in women of different ages during the reproductive period and in patients with ovulatory disorders. The study compares the periodicity, amplitude, and phase changes of Clock/Bmal1-TTFLs-klotho related proteins and genes in PCOS, DOR patients, and age-matched women with normal ovarian function, aiming to identify the key segments of ovarian clock gene period rhythm disorder under different disease states, and screen the key time points of clock gene oscillation abnormality. Omics analysis of the differences between groups, analysis of the relationship between gene transcription translation, protein expression, metabolites, and the expression of clock genes, and deduction of the dynamic changes and interaction relationships of the biological processes within the ovaries in regulating ovulatory disorders using the method of reinforcing the kidney and regulating the menstrual cycle. This aims to clarify that maintaining the ovarian biological clock period rhythm is an important biological basis for "the kidney dominating reproduction". The regulation mechanism of the treatment of ovulatory disorders using the method of reinforcing the kidney and regulating the menstrual cycle is explained from the perspective of the ovarian biological clock period rhythm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- (i) Types of trial design: Multicentre, prospective, cross-sectional study; multicentre, prospective, double-blind, randomised controlled trial. (II) Principles of trial design 1. Number of cases: A total of 650 cases were included in the study, including 300 healthy women of reproductive age (divided into three groups according to age: 21-27 years old, 28-34 years old, 35-41 years old, 100 cases in each group), 150 cases of women with normal ovarian function who underwent in vitro fertilization-embryo transplantation (IVF-ET) due to male factor (divided into three groups according to age: 21-27 years old, 28-34 years old, 35-41 years old, 100 cases in each group). 34 years old, 35-41 years old, 50 cases in each group), 100 cases of PCOS infertility, 100 cases of DOR infertility. 2. Random control: According to the accepted principles of validity, safety and comparability, SPSS 27 statistical software, define the random seed number '20240001', according to 1:1 to generate the random se
| Arm | Type | Receives |
|---|---|---|
| Chinese medicine treatment group（PCOS） | Experimental | Drug: a compound prescription of Chinese medicineBeginning on day 5 of the menstrual cycle, the treatment group was treated with a combination of Zi Yin and Yang Formula sequential treatment based on the control group, and Zi Yin and Yang Formula sequential treatment (Tuning Zhou Zi Yin Granules + Tuning Zhou and Yang Granules) was used in the 3 menstrual cycles prior to the IVF advancement week. Starting on the 5th day of the menstrual cycle, take the Tuning Zhou Zi Yin Granules (in-hospital preparation) orally. 2 packets each time, 3 times a day, 14 days of treatment; regulating Zhou Zhi Yin Granules (hospital preparation development), oral. Take 2 sachets each time, 3 times a day for 14 days. |
| Chinese medicine treatment group（DOR） | Experimental | Drug: a compound prescription of Chinese medicineBeginning on day 5 of the menstrual cycle, the treatment group was treated with a combination of Zi Yin and Yang Formula sequential treatment based on the control group, and Zi Yin and Yang Formula sequential treatment (Tuning Zhou Zi Yin Granules + Tuning Zhou and Yang Granules) was used in the 3 menstrual cycles prior to the IVF advancement week. Starting on the 5th day of the menstrual cycle, take the Tuning Zhou Zi Yin Granules (in-hospital preparation) orally. 2 packets each time, 3 times a day, 14 days of treatment; regulating Zhou Zhi Yin Granules (hospital preparation development), oral. Take 2 sachets each time, 3 times a day for 14 days. |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) meet the diagnostic criteria of infertility; 2) aged between 28 and 34 years old; 3) meet the diagnostic criteria of PCOS or DOR and the Chinese medicine diagnosis is kidney deficiency, or the ovarian function is normal in the case of IVF fertilization due to the male factor; 4) assisted in fertilization with IVF-ET antagonist or microstimulation; 5) the patients can tolerate the relevant treatment of the present study, and the compliance is good; 6) they have not used any medication before the treatment and have signed the informed consent. 7) Patients who have not used any medication before the treatment and have signed the informed consent for enrollment.
Key exclusion criteria (1 listed)
- 1) Age > 35 years old; 2) Body mass index (BMI) ≥ 25kg/m2; 3) Abnormal karyotype of either spouse; 4) Uterine infertility, such as endometrial polyps, uterine adhesions, submucosal fibroids, adenomyosis, congenital uterine anomalies, etc.; 5) Endometriosis; 6) Repeated abortion; 7) Untreated hydrosalpinx; 8) Those who had used endocrine-affecting drugs in the last three months; 9) Combination of other contraindications to assisted reproduction techniques for conception such as psychiatric disorders, severely impaired liver or kidney function, thrombotic disorders, and malignant tumors.10) Those who were unable to give full informed consent due to intellectual or behavioral disabilities.11) Suspected or confirmed history of alcohol or drug abuse.12) According to the investigator's judgment (12) Other medical conditions that, in the judgment of the investigator, reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment that may result in loss of visits.13) Allergy, such as a history of allergy to two or more medications or foods, or a known allergy to the components of the medication.14) Patients participating in a clinical trial of another medication.
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 |
|---|---|---|
| a compound prescription of Chinese medicineThe enrolled patients were treated with 3 cycles of sequential treatment with Nourishing Yin and Replenishing Yang formula before entering the cycle (Tuning Weekly Nourishing Yin Granules + Tuning Weekly Replenishing Yang Granules), and the egg retrieval cycle used an antagonist regimen to obtain the eggs. | Drug | Chinese medicine treatment group（DOR）, Chinese medicine treatment group（PCOS） |
Primary outcome
Human data
Time frame: Main symptoms and signs: first day of the initial consultation, the third day of the menstrual cycle without entering the treatment cycle, the day of egg collection, and 14 days after the FET are each observed and recorded once.
Serum indicators: Serum was collected on the 3rd and 21st day of the menstrual cycle before entering the treatment cycle, and ELISA was performed to detect changes in the amount of Bmal1, Clock, klotho, Per1, Per2, Per3, Cry1, Cry2, AMH, INHB, and sex hormones (E2, FSH, LH, P, and T) in the serum. (2) Follicular fluid index: follicular fluid was retained on the day of ovulation, and changes in the concentration of Bmal1, Clock, klotho, AMH, INHB, and sex hormones (E2, FSH, LH, P, and T) in the follicular fluid were detected by ELISA. (3) Granulosa cell indexes: Ovarian granulosa cells were cultured in vitro for 24 hours on the day of egg collection, and changes in mRNA and protein of the ovarian clock genes Bmal1, Clock, klotho, Per1, Per2, Per3, Cry1 and Cry2 were detected by qPCR and WB at 3-hour intervals. (4) Histological indicators: follicular fluid and ovarian granulosa cells were retained on the day of egg collection for UPLC-Q-TOF/MS metabolomics, whole genome microarray genom
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 11 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing a compound prescription of Chinese medicine in people with Polycystic Ovary Syndrome and Diminished Ovarian Reserve, run by Affiliated Hospital of Nanjing University of Chinese Medicine 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 11 Feb 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human data (time frame: Main symptoms and signs: first day of the initial consultation, the third day of the menstrual cycle without entering the treatment cycle, the day of egg collection, and 14 days after the FET are each observed and recorded once.). 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 11 Feb 2025.