Warm NeedlingNCT05874518
Clinical Observation of Warm Needling Combined With and Electroacupuncture Therapy on Ovulatory Dysfunction
A study testing warm needling combined with electroacupuncture and The treatment with letrozole tablets was started on the fifth day of the menstrual cycle in people with Warm Needling and Electroacupuncture, run by Liuzhou Maternity and Child Healthcare Hospital at 1 site in China.
Trial summary
To observe the effect of warm needling combined with electroacupuncture on the ovulation promotion rate and pregnancy rate in luteinized unruptured follicle syndrome (LUFS). Read more about this study
- Who is it for?
- Ages 23 to 48 years, women only
- Conditions the study is for
- Warm Needling, Electroacupuncture, Ovulation Dysfunction
- What is being tested?
- warm needling combined with electroacupuncture and The treatment with letrozole tablets was started on the fifth day of the menstrual cycle
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Apr 2022
- Phase
- Interventional
- 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 23 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility diagnosis criteria refer to the "Obstetrics and Gynecology" [10]: Infertility refers to the patient fails to conceive a pregnancy with normal sexual life and without contraception for 1 year. In primary infertility, pregnancy has never occurred. In secondary infertility, patients have previously conceived, but are unable to conceive again without contraception for 1 year.
- The standard for ovulation infertility is formulated according to the first series of Guiding Principles for Clinical Research of New Chinese Medicine: Basal body temperature was continuously recorded for single phase for more than 3 months; Vaginal detached cell smear examination showed no significant periodic changes; Cervical mucus crystallization examination showed no periodic changes, and ellipsoid; There was no typical secretory period change in endometrial examination on 6 days before menstruation; a series of B-ultrasound monitoring showed no ovulation signs; Blood and urinary progesterone levels were lower than those in the luteal phase. Patients who met two of the above 6 items could be diagnosed with anovulation
Who cannot join
- Those who have any serious adverse reactions during the treatment process and cannot continue the treatment
- Failing to follow the treatment plan and receiving other treatment
- Patients who quit the treatment process by themselves, or who have an incomplete course of treatment, will have a negative effect on the curative effect
Trial locations and contacts
1 site in 1 country.
About this study
To observe the effect of warm needling combined with electroacupuncture on the ovulation promotion rate and pregnancy rate in luteinized unruptured follicle syndrome (LUFS).
- Conditions
- Warm Needling, Electroacupuncture, Ovulation Dysfunction
- Being tested
- warm needling combined with electroacupuncture, The treatment with letrozole tablets was started on the fifth day of the menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warm needling combined with electroacupunctureOther
Treatment begins on the 5th day of the menstrual cycle, qd (once a day), usually for 6-8 consecutive days, and continuing to the day of ovulation.
The treatment with letrozole tablets was started on the fifth day of the menstrual cycleDrug
Letrozole tablets were given at 2.5mg (Jiangsu Hengrui Pharmaceutical Co., Ltd., H19991001, 2.5mg per tablet), po (oral), qd, for 5-7 consecutive days. When the diameter of follicles reaches 18mm, Chorionic gonadotrophin is given at 5000u (Lizhu Group Lizhu Pharmaceutical Factory, Chinese medicine H44020668, 5000u per branch), with intramuscular injection, qd, to promote follicle discharge. Patients were also instructed to have sexual intercourse on the same day and on day 2.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Ask the patient to empty the bladder, and take supine position. Take guanyuan, zhongji, bilateral Tianshu, zigong, guilai, sanyinjiao, Taixi, zusanli, hegu points. Select 0.3mm×40mm fine needles. After conventional disinfection, the needle is 0.5-1 inch deep. Then the 1.5 cm moxa cones were inserted into the tail of the needle of the bilateral sanyinjioa and zusnli points for moxibustion. At the same time, electroacupuncture therapy was used. Select the density wave and set the time for 25 minutes.
Generally, the patient feels comfortable as moderate, so that the patient feel acid, distension, heat or local muscles for rhythmic contraction. After treatment, first reduce the power to zero value, turn off the power supply, then remove the electrode clip from the needle handle, and pull out the fine needle stabbed into the tissue. Treatment begins on the 5th day of the menstrual cycle, qd (once a day), usually for 6-8 consecutive days, and continuing to the day of ovulation. Receives: Other: warm needling combined with electroacupuncture |
| Control group | Active comparator | Treatment was started on day 5 of the menstrual cycle. Letrozole tablets were given at 2.5mg (Jiangsu Hengrui Pharmaceutical Co., Ltd., H19991001, 2.5mg per tablet), po (oral), qd, for 5-7 consecutive days. When the diameter of follicles reaches 18mm, Chorionic gonadotrophin is given at 5000u (Lizhu Group Lizhu Pharmaceutical Factory, Chinese medicine H44020668, 5000u per branch), with intramuscular injection, qd, to promote follicle discharge. Patients were also instructed to have sexual intercourse on the same day and on day 2. Receives: Drug: The treatment with letrozole tablets was started on the fifth day of the menstrual cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound characteristics of ovulation
Monitoring follicular intima thickness
Measured: About 10 days on average until ≥18mm follicle disappears or 20mm follicle volume decreases
vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
Measured: the endometrium of ≥8mm on the fifth day of menstruation
Use vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
When the follicle size reached 18mm and Chorionic gonadotrophin was injected
Measured: 48 hours after chorionic gonadotropin injection
Pregnancy judgment
Pregnancy was determined by detecting serum HCG (human chorionic gonadotropin) 14 days after ovulation
Measured: 14 days after ovulation
Pregnancy judgment
At about 50 days of pregnancy, pregnancy sac or fetal heart beat through vaginal B ultrasound
Measured: about 50 days of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Warm NeedlingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liuzhou Maternity and Child Healthcare Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanghua Yang, Liuzhou Maternity and Child Healthcare Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874518
- Sponsor's protocol ID
- LiuzhouMCHH
- Status last verified
- May 2023
- First submitted
- 11 Apr 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Warm Needling Combined With and Electroacupuncture Therapy on Ovulatory Dysfunction
- ClinicalTrials.gov ID
- NCT05874518
- Acronym / sponsor ID
- LiuzhouMCHH
- Conditions
- Warm Needling, Electroacupuncture, Ovulation Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Liuzhou Maternity and Child Healthcare HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 25 May 2023 (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.
To observe the effect of warm needling combined with electroacupuncture on the ovulation promotion rate and pregnancy rate in luteinized unruptured follicle syndrome (LUFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: warm needling combined with electroacupunctureAsk the patient to empty the bladder, and take supine position. Take guanyuan, zhongji, bilateral Tianshu, zigong, guilai, sanyinjiao, Taixi, zusanli, hegu points. Select 0.3mm×40mm fine needles. After conventional disinfection, the needle is 0.5-1 inch deep. Then the 1.5 cm moxa cones were inserted into the tail of the needle of the bilateral sanyinjioa and zusnli points for moxibustion. At the same time, electroacupuncture therapy was used. Select the density wave and set the time for 25 minutes. Generally, the patient feels comfortable as moderate, so that the patient feel acid, distension, heat or local muscles for rhythmic contraction. After treatment, first reduce the power to zero value, turn off the power supply, then remove the electrode clip from the needle handle, and pull out the fine needle stabbed into the tissue. Treatment begins on the 5th day of the menstrual cycle, qd (once a day), usually for 6-8 consecutive days, and continuing to the day of ovulation. |
| Control group | Active comparator | Drug: The treatment with letrozole tablets was started on the fifth day of the menstrual cycleTreatment was started on day 5 of the menstrual cycle. Letrozole tablets were given at 2.5mg (Jiangsu Hengrui Pharmaceutical Co., Ltd., H19991001, 2.5mg per tablet), po (oral), qd, for 5-7 consecutive days. When the diameter of follicles reaches 18mm, Chorionic gonadotrophin is given at 5000u (Lizhu Group Lizhu Pharmaceutical Factory, Chinese medicine H44020668, 5000u per branch), with intramuscular injection, qd, to promote follicle discharge. Patients were also instructed to have sexual intercourse on the same day and on day 2. |
Who may qualify
- Ages
- 23 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertility diagnosis criteria refer to the "Obstetrics and Gynecology" [10]: Infertility refers to the patient fails to conceive a pregnancy with normal sexual life and without contraception for 1 year. In primary infertility, pregnancy has never occurred. In secondary infertility, patients have previously conceived, but are unable to conceive again without contraception for 1 year.
- The standard for ovulation infertility is formulated according to the first series of Guiding Principles for Clinical Research of New Chinese Medicine: Basal body temperature was continuously recorded for single phase for more than 3 months; Vaginal detached cell smear examination showed no significant periodic changes; Cervical mucus crystallization examination showed no periodic changes, and ellipsoid; There was no typical secretory period change in endometrial examination on 6 days before menstruation; a series of B-ultrasound monitoring showed no ovulation signs; Blood and urinary progesterone levels were lower than those in the luteal phase. Patients who met two of the above 6 items could be diagnosed with anovulation
Key exclusion criteria (3 listed)
- Those who have any serious adverse reactions during the treatment process and cannot continue the treatment
- Failing to follow the treatment plan and receiving other treatment
- Patients who quit the treatment process by themselves, or who have an incomplete course of treatment, will have a negative effect on the curative effect
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 |
|---|---|---|
| warm needling combined with electroacupunctureTreatment begins on the 5th day of the menstrual cycle, qd (once a day), usually for 6-8 consecutive days, and continuing to the day of ovulation. | Other | Experimental group |
| The treatment with letrozole tablets was started on the fifth day of the menstrual cycleLetrozole tablets were given at 2.5mg (Jiangsu Hengrui Pharmaceutical Co., Ltd., H19991001, 2.5mg per tablet), po (oral), qd, for 5-7 consecutive days. When the diameter of follicles reaches 18mm, Chorionic gonadotrophin is given at 5000u (Lizhu Group Lizhu Pharmaceutical Factory, Chinese medicine H44020668, 5000u per branch), with intramuscular injection, qd, to promote follicle discharge. Patients were also instructed to have sexual intercourse on the same day and on day 2. | Drug | Control group |
Primary outcome
Ultrasound characteristics of ovulation
Time frame: About 10 days on average until ≥18mm follicle disappears or 20mm follicle volume decreases
Monitoring follicular intima thickness
vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
Time frame: the endometrium of ≥8mm on the fifth day of menstruation
vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
Use vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
Time frame: 48 hours after chorionic gonadotropin injection
When the follicle size reached 18mm and Chorionic gonadotrophin was injected
Pregnancy judgment
Time frame: 14 days after ovulation
Pregnancy was determined by detecting serum HCG (human chorionic gonadotropin) 14 days after ovulation
Pregnancy judgment
Time frame: about 50 days of pregnancy
At about 50 days of pregnancy, pregnancy sac or fetal heart beat through vaginal B ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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.
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 study testing warm needling combined with electroacupuncture and The treatment with letrozole tablets was started on the fifth day of the menstrual cycle in people with Warm Needling and Electroacupuncture, run by Liuzhou Maternity and Child Healthcare 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultrasound characteristics of ovulation (time frame: About 10 days on average until ≥18mm follicle disappears or 20mm follicle volume decreases). 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?
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 25 May 2023.