Decreased Ovarian ReserveNCT06332742
Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased
An observational study of Decreased Ovarian Reserve, run by Yun Chen at 1 site in China.
Trial summary
A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Decreased Ovarian Reserve
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 1. Those who meet the diagnostic criteria for hypoovarian reserve disease and the TCM syndrome differentiation criteria for heart and kidney disharmony. 2. Aged between 25 and 45 years old, female. 3. Informed consent and voluntary participation. 4. The process of obtaining informed consent should comply with GCP regulations.
1.AMH AMH <1.1ng/ml 2.AFC: AFC <5~7 ovaries on both sides 3.Basic FSH: Basal FSH for two consecutive menstrual cycles ≥10 IU/L 4.Aged between 25 and 45 years old, female.
- Those with reduced ovarian function caused by ovarian or uterine surgery, radiotherapy and chemotherapy;
- Liver function (AST or ALT) and renal function (BUN or Ccr) are greater than 2 times the normal value;
- Patients with a history of mental illness or legal disability
- Those who have used endocrine-affecting drugs within 3 months before the study, estrogen, progesterone or related compound preparations, oral contraceptive pills, Chinese medicines or Chinese patent medicines related to the treatment of premature ovarian failure. Our hospital's preparations include Wu Turtle Rejuvenation Oral Liquid and Kuntai Capsules.
- Patients with unexplained irregular vaginal bleeding
- Patients who are participating in clinical trials of other drugs
- For women who want to have children, those whose spouse's semen test fails to meet the standard will be excluded.
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
Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210023
Chen Yun, 8613675167221, 66teoyq@gmail.com
About this study
Official title: Real-world Evaluation of the Clinical Efficacy of Qingxin Zishen Decoction in Patients With Reduced Ovarian Reserve
A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction
- Conditions
- Decreased Ovarian Reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposome group | 5g lotus seed heart, 3g coptis, 15g uncaria, 15g fried jujube kernel, 10g dried rehmannia glutinosa, 9g dogwood meat, 10g salvia miltiorrhiza, 30g floating wheat. 1 dose per day, decocted in water twice, 200ml each time, taken warmly after breakfast and dinner | |
| Non-exposed group | All patients who met the inclusion criteria and did not use Qingxin Zishen Decoction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional Chinese medicine syndrome score
Traditional Chinese medicine syndrome score
Measured: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
serum sex hormone levels
SHBG stands for sex hormone binding globulin. It's a protein made mostly in your liver. It binds (attaches) to sex hormones in your blood.
Measured: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
serum AMH levels
An AMH test measures levels of anti-mullerian hormone, which corresponds to a person's egg count.
Measured: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC)
Antral follicle count is rightly done on day 3 of the cycle by a Trans vaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated.
Measured: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
Secondary outcomes (2)
Seven items of thyroid function
The thyroid gland produces hormones that regulate the body's metabolic rate, growth and development. It plays a role in controlling heart, muscle and digestive function, brain development and bone maintenance.
Measured: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
natural pregnancy rate
A woman in her early to mid-20s has a 25-30% chance of getting pregnant every month. Fertility generally starts to slowly decline when a woman is in her early 30s, and after the age of 35 the decline speeds up. By age 40, the chance of getting pregnant in any monthly cycle is around 5%.
Measured: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decreased Ovarian ReserveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Yun Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Chen, Jiangsu Province Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332742
- Sponsor's protocol ID
- QXZS for DOR
- Status last verified
- Apr 2024
- First submitted
- 3 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of the Clinical Efficacy of Qingxin Zishen Decoction in Patients With Reduced Ovarian Reserve
- ClinicalTrials.gov ID
- NCT06332742
- Acronym / sponsor ID
- QXZS for DOR
- Conditions
- Decreased Ovarian Reserve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Yun ChenUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 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.
A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposome group | – | –5g lotus seed heart, 3g coptis, 15g uncaria, 15g fried jujube kernel, 10g dried rehmannia glutinosa, 9g dogwood meat, 10g salvia miltiorrhiza, 30g floating wheat. 1 dose per day, decocted in water twice, 200ml each time, taken warmly after breakfast and dinner |
| Non-exposed group | – | –All patients who met the inclusion criteria and did not use Qingxin Zishen Decoction. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Those who meet the diagnostic criteria for hypoovarian reserve disease and the TCM syndrome differentiation criteria for heart and kidney disharmony. 2. Aged between 25 and 45 years old, female. 3. Informed consent and voluntary participation. 4. The process of obtaining informed consent should comply with GCP regulations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Traditional Chinese medicine syndrome score
Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
Traditional Chinese medicine syndrome score
serum sex hormone levels
Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
SHBG stands for sex hormone binding globulin. It's a protein made mostly in your liver. It binds (attaches) to sex hormones in your blood.
serum AMH levels
Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
An AMH test measures levels of anti-mullerian hormone, which corresponds to a person's egg count.
transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC)
Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
Antral follicle count is rightly done on day 3 of the cycle by a Trans vaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated.
2 secondary outcomes
Seven items of thyroid function
Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
natural pregnancy rate
Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
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 4 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Decreased Ovarian Reserve
Not yet recruiting
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Diminished Ovarian Reserve (DOR)
Recruiting
Improving Women's Fertility Awareness and Reducing Anxiety Through Ovarian Reserve Screening and AI Counseling
Fertility Awareness, Ovarian Reserve
RecruitingPhase 1
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Infertility, Obesity
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
Not yet recruitingEarly Phase 1
Guishen Yijing Granules for Diminished Ovarian Reserve With Kidney Deficiency Syndrome: A Randomized Controlled Trial
Diminished Ovarian Reserve (DOR)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decreased Ovarian Reserve, run by Yun Chen 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?
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 4 Apr 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 Chen Yun (8613675167221, 66teoyq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traditional Chinese medicine syndrome score (time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment). The study lists 4 primary outcomes in all. 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 4 Apr 2024.