PCOSPhase 1PCOSNCT04987632
Effect of Acupuncture Plus Governor Vessel Moxibustion Combined With Letrozole on Live Birth in Anovulatory Infertile Women With Spleen-kidney Yang Deficiency PCOS
A Phase 1 study testing Letrozole, acupuncture and Governor vessel moxibustion in people with PCOS and Infertility, Female, run by Qiu-ping Lin.
Trial summary
Investigators expected to verify this hypothesis through this study:acupuncture and moxibustion combined with LE induced ovulation in Chinese anovulatory PCOS women has a higher rate of live birth than LE induced ovulation alone. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCOS, Infertility, Female
- What is being tested?
- Letrozole, acupuncture and Governor vessel moxibustion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2021to 31 Dec 2022
- Phase
- Phase 1
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the ages of 20 and 40.
- It meets the diagnostic criteria of spleen-kidney Yang deficiency type PCOS.
- According to World Health Organization standards (2010), the husband's semen analysis meets ① or ②.①Sperm density ≥15×10^6/ml, and motile sperm (forward and non-forward) ≥40% (A + B + C ≥40%)).② Total motile sperm number ≥9 million.That is, the percentage of semen volume × semen density × motility sperm ≥9×10^6.
- Tubal patency tests, including hysterosalpingography and diagnostic laparoscopy, which show that at least one fallopian tube is open.(If there is no history of pelvic operation or abortion, patency test results are effective within 3 years;If there is a history of fertility within 5 years and there is no pelvic operation, the tubal patency test is not required).
- Agree to discontinue the use of other therapies during the study. 6) Participate in the study voluntarily and sign the informed consent.
Who cannot join
- Eliminate other endocrine disorders: ① Patients with hyperprolactinemia (defined as two prolactin levels greater than or equal to 25ng/ml or determined by local standard values at least one week apart).The goal of excluding patients with hyperprolactinemia was to reduce variability among PCOS patients.These patients may be treated with alternative therapies (e.g., dopamine agonists).Those who had received treatment within the past year or were receiving treatment with normal test values could be enrolled. ② Menopausal FSH level (> 15 mIU/mL).Normal levels in the past year are eligible for inclusion. ③ Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL).In the past year, normal levels can be included in the group. ④ Patients with poorly controlled type I or II diabetes (defined as a bb0 7.0% glycosylated hemoglobin level) or patients receiving antidiabetic drugs such as insulin, thiazole-lowering drugs, acarbose, or sulfonylureas may obfuscate the effects of the study drugs;Patients who were being treated with metformin in order to be diagnosed with type I or II diabetes or PCOS also need to be excluded. ⑤ Suspected patients with Cushing syndrome.
- In the last 2 months, use of hormones or other drugs, including TCM prescriptions and Chinese patent medicines, may affect the results.
- Pregnancy history within the last 6 weeks.
- A history of miscarriage or birth in the last 6 weeks.
- A history of breastfeeding in the last 6 months.
- Do not agree to sign the informed consent for this study.
- PCOS women who do not belong to the syndrome of spleen-kidney Yang deficiency.
- Special exclusion criteria: ① Patients with adrenal or ovarian tumors suspected of producing androgens. ② Both the husband and wife have had sterilization operations (vasectomy, tubal ligation) before, and the ligation has been loosened.Previous surgery may have influenced the results of the study.Patients with both husband and wife having undergone sterilization and PCOS at the same time are rare, and the inclusion of these patients should be excluded, otherwise the progress of this study will be affected. ③ Patients who have had bariatric surgery recently (<12 months) and who are in a period of dramatic weight loss or who have had bariatric surgery to prohibit pregnancy. ④ Untreated hypertensive patients with poor blood pressure control were defined as ≥60min between two blood pressure measurements, ≥160 mm Hg systolic or ≥100 mm Hg diastolic. ⑤ Patients with known congenital adrenocortical hyperplasia. ⑥ Oral ontraceptives, progesterone or hormone implants (including subcutaneous implants).A 2-month clearance period is required before screening of patients who have received these drugs.Storage of contraceptive forms or implants, especially if the implants have not been removed, may require longer removal time.Oral contraceptives take about a month to clear the drug. ⑦ Patients with liver disease with AST or ALT >2 times normal value or total bilirubin >2.5 g/dL.Patients with nephropathy with BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL. ⑧ Patients with significant anemia (hemoglobin < 10 g/dL). ⑨Patients with a history of deep vein thrombosis, pulmonary embolism, or cerebrovascular disease .⑩ Patients with heart disease that may worsen after pregnancy. ⑪ Patients with a suspected history of cervical, endometrial or breast cancer.Women 21 years of age and older should have normal results from a Pap smear or TCT test. ⑫ Patients with a current history of alcoholism.Binge drinking was defined as > 14 times a week or binge drinking. ⑬ Patients also participated in other clinical studies.These studies require medication, sex restriction, or other barriers to compliance. ⑭ Patients who are expected to discontinue treatment for more than 1 month during the study period should not be included. ⑮ Patients taking other medications known to affect reproductive function or metabolism.These drugs include oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs, anti-diabetic drugs such as metformin and thiazolidindiones, growth hormone release inhibiting hormones, diazazines, ACE inhibitors, and calcium channel blockers.The removal time of the above drugs should be 2 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Acupuncture Plus Governor Vessel Moxibustion Combined With Letrozole on Live Birth in Anovulatory Infertile Women With Spleen-kidney Yang Deficiency Polycystic Ovary Syndrome: a Randomised Controlled Trial
Investigators expected to verify this hypothesis through this study:acupuncture and moxibustion combined with LE induced ovulation in Chinese anovulatory PCOS women has a higher rate of live birth than LE induced ovulation alone.
Read the detailed description
It is a prospective, single center, clinical, randomized, controlled study. The subjects were 90 PCOS anovulatory participants of spleen kidney yang deficiency type, aged 20-40 years, who were treated in the outpatient department of Obstetrics and Gynecology of Dongguan Hospital of traditional Chinese medicine from January 2021 to December 2022. Participants were randomly divided into two groups: Acupuncture plus Du Meridian moxibustion combined with LE ovulation induction treatment group and single Le ovulation induction control group, 45 cases in each group.
The subjects in the two groups began to take letrozole or combined with acupuncture and Du Meridian moxibustion on 3-5 days of menstruation (spontaneous menstruation or progesterone withdrawal bleeding). If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation or acupuncture plus Du Meridian moxibustion. Once pregnancy is found, acupuncture and Du Meridian moxibustion or drug treatment will stop immediately.
At the end of treatment, data were collected to observe the differences of live birth rate, pregnancy rate, ovulation rate, sex hormone, steroid hormone, glucose and lipid metabolism index and safety index between the two groups.
- Conditions
- PCOS, Infertility, Female
- Being tested
- Letrozole, acupuncture, Governor vessel moxibustion
- Keywords
- PCOS, acupuncture, Governor vessel moxibustion, spleen-kidney Yang deficiency, letrozole
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.
acupunctureDevice
Domestic and foreign studies suggest that acupuncture and electroacupuncture can improve the menstrual cycle of PCOS and reduce the level of total testosterone; Acupuncture can regulate glucose homeostasis by stimulating the autonomic nervous system of PCOS patients. Our previous studies and a large number of literatures have proved that acupuncture can improve insulin resistance in PCOS, and acupuncture can improve the pregnancy rate in PCOS.
Governor vessel moxibustionOther
It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation
| Study group | Role | What they receive |
|---|---|---|
| Letrozole combined with acupuncture and Du Meridian moxibustion group | Experimental | Letrozole combined with acupuncture and Du Meridian moxibustion was taken from 3-5 days of menstrual period (spontaneous menstruation or progesterone withdrawal bleeding). The acupuncture treatment was 3 times / week, with an interval of 2-4 days, 12 times a week, 30 minutes each time; Du Meridian moxibustion is 20 minutes each time, once a week, four times a week. The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation with acupuncture plus Du Meridian moxibustion. Receives: Drug: Letrozole; Device: acupuncture; Other: Governor vessel moxibustion |
| Letrozole group | Active comparator | Letrozole was taken 3-5 days after menstruation (spontaneous menstruation or progesterone withdrawal bleeding). The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. In the absence of pregnancy, subjects were treated with letrozole for up to four cycles. Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Ratio of the number ofdelivery of a live-born infant to the total number pregnancies of trials.
Measured: Within 1 year after the end of Cycle 4 (each cycle is 28 days).
Clinical pregnancy rate
Ratio of the number of pregnancies to the total number of trials.
Measured: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Secondary outcomes (6)
Ovulation rate
Ratio of total ovulation times to the sum of the number of trials in each cycle(each cycle is 28 days).
Measured: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Multiple pregnancy rate
The rate of multiple pregnancies to total pregnancies.
Measured: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Abortion rate
Ratio of miscarriage in the total number of pregnancies.
Measured: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
HOMA-IR
Insulin resistance index is equal to fasting blood glucose multiplied by fasting insulin ratio 22.5. Recently, it was proposed that insulin resistance should be judged when it is greater than 2.69
Measured: Before the trail and at the end of cycle 4.
Metabolic blood test
Number of Participants with abnormal liver function, renal function, blood lipid, blood glucose, blood pressure and other metabolic indicators.
Measured: Before the trail and at the end of cycle 4.
Adverse reactions
It refers to the harmful reaction that has nothing to do with the purpose of treatment in the process of using drugs to prevent, diagnose or treat diseases according to the normal usage and dosage.
Measured: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start3 Aug 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiu-ping Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiu-ping Lin, Dongguan Hospital of Traditional Chinese Medicine
- Investigators
- naiping wang, Chief physician, Study director, Dongguan Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987632
- Sponsor's protocol ID
- 20211408
- Acronym
- PCOS
- Status last verified
- Aug 2021
- First submitted
- 15 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results were published within 6 months after the completion of the test.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture Plus Governor Vessel Moxibustion Combined With Letrozole on Live Birth in Anovulatory Infertile Women With Spleen-kidney Yang Deficiency Polycystic Ovary Syndrome: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04987632
- Acronym / sponsor ID
- PCOS / 20211408
- Conditions
- PCOS, Infertility, Female
- Keywords
- PCOS, acupuncture, Governor vessel moxibustion, spleen-kidney Yang deficiency, letrozole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Qiu-ping LinUniversity, hospital or other
- Study start
- 3 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Aug 2021 (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 expected to verify this hypothesis through this study:acupuncture and moxibustion combined with LE induced ovulation in Chinese anovulatory PCOS women has a higher rate of live birth than LE induced ovulation alone.
Detailed description
It is a prospective, single center, clinical, randomized, controlled study. The subjects were 90 PCOS anovulatory participants of spleen kidney yang deficiency type, aged 20-40 years, who were treated in the outpatient department of Obstetrics and Gynecology of Dongguan Hospital of traditional Chinese medicine from January 2021 to December 2022. Participants were randomly divided into two groups: Acupuncture plus Du Meridian moxibustion combined with LE ovulation induction treatment group and single Le ovulation induction control group, 45 cases in each group.
The subjects in the two groups began to take letrozole or combined with acupuncture and Du Meridian moxibustion on 3-5 days of menstruation (spontaneous menstruation or progesterone withdrawal bleeding). If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation or acupuncture plus Du Meridian moxibustion. Once pregnancy is found, acupuncture and Du Meridian moxibustion or drug treatment will stop immediately.
At the end of treatment, data were collected to observe the differences of live birth rate, pregnancy rate, ovulation rate, sex hormone, steroid hormone, glucose and lipid metabolism index and safety index between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole combined with acupuncture and Du Meridian moxibustion group | Experimental | Drug: Letrozole, Device: acupuncture, Other: Governor vessel moxibustionLetrozole combined with acupuncture and Du Meridian moxibustion was taken from 3-5 days of menstrual period (spontaneous menstruation or progesterone withdrawal bleeding). The acupuncture treatment was 3 times / week, with an interval of 2-4 days, 12 times a week, 30 minutes each time; Du Meridian moxibustion is 20 minutes each time, once a week, four times a week. The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation with acupuncture plus Du Meridian moxibustion. |
| Letrozole group | Active comparator | Drug: LetrozoleLetrozole was taken 3-5 days after menstruation (spontaneous menstruation or progesterone withdrawal bleeding). The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. In the absence of pregnancy, subjects were treated with letrozole for up to four cycles. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the ages of 20 and 40.
- It meets the diagnostic criteria of spleen-kidney Yang deficiency type PCOS.
- According to World Health Organization standards (2010), the husband's semen analysis meets ① or ②.①Sperm density ≥15×10^6/ml, and motile sperm (forward and non-forward) ≥40% (A + B + C ≥40%)).② Total motile sperm number ≥9 million.That is, the percentage of semen volume × semen density × motility sperm ≥9×10^6.
- Tubal patency tests, including hysterosalpingography and diagnostic laparoscopy, which show that at least one fallopian tube is open.(If there is no history of pelvic operation or abortion, patency test results are effective within 3 years;If there is a history of fertility within 5 years and there is no pelvic operation, the tubal patency test is not required).
- Agree to discontinue the use of other therapies during the study. 6) Participate in the study voluntarily and sign the informed consent.
Key exclusion criteria (8 listed)
- Eliminate other endocrine disorders: ① Patients with hyperprolactinemia (defined as two prolactin levels greater than or equal to 25ng/ml or determined by local standard values at least one week apart).The goal of excluding patients with hyperprolactinemia was to reduce variability among PCOS patients.These patients may be treated with alternative therapies (e.g., dopamine agonists).Those who had received treatment within the past year or were receiving treatment with normal test values could be enrolled. ② Menopausal FSH level (> 15 mIU/mL).Normal levels in the past year are eligible for inclusion. ③ Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL).In the past year, normal levels can be included in the group. ④ Patients with poorly controlled type I or II diabetes (defined as a bb0 7.0% glycosylated hemoglobin level) or patients receiving antidiabetic drugs such as insulin, thiazole-lowering drugs, acarbose, or sulfonylureas may obfuscate the effects of the study drugs;Patients who were being treated with metformin in order to be diagnosed with type I or II diabetes or PCOS also need to be excluded. ⑤ Suspected patients with Cushing syndrome.
- In the last 2 months, use of hormones or other drugs, including TCM prescriptions and Chinese patent medicines, may affect the results.
- Pregnancy history within the last 6 weeks.
- A history of miscarriage or birth in the last 6 weeks.
- A history of breastfeeding in the last 6 months.
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 |
|---|---|---|
| LetrozoleLetrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS. | Drug | Letrozole combined with acupuncture and Du Meridian moxibustion group, Letrozole group |
| acupunctureDomestic and foreign studies suggest that acupuncture and electroacupuncture can improve the menstrual cycle of PCOS and reduce the level of total testosterone; Acupuncture can regulate glucose homeostasis by stimulating the autonomic nervous system of PCOS patients. Our previous studies and a large number of literatures have proved that acupuncture can improve insulin resistance in PCOS, and acupuncture can improve the pregnancy rate in PCOS. | Device | Letrozole combined with acupuncture and Du Meridian moxibustion group |
| Governor vessel moxibustionIt can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation | Other | Letrozole combined with acupuncture and Du Meridian moxibustion group |
Primary outcome
live birth rate
Time frame: Within 1 year after the end of Cycle 4 (each cycle is 28 days).
Ratio of the number ofdelivery of a live-born infant to the total number pregnancies of trials.
Clinical pregnancy rate
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Ratio of the number of pregnancies to the total number of trials.
6 secondary outcomes
Ovulation rate
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Multiple pregnancy rate
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Abortion rate
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
HOMA-IR
Time frame: Before the trail and at the end of cycle 4.
Metabolic blood test
Time frame: Before the trail and at the end of cycle 4.
Adverse reactions
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: Yes. The results were published within 6 months after the completion of the test.
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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.
naiping wang, Chief physician study director
Dongguan Hospital of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Letrozole, acupuncture and Governor vessel moxibustion in people with PCOS and Infertility, Female, run by Qiu-ping Lin.
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 5 inclusion and 8 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
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 kewei Quan, attending doctor (0086 13416820860, 279271961@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: Within 1 year after the end of Cycle 4 (each cycle is 28 days).). The study lists 2 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 3 Aug 2021.