Irregular MensesPhase 1NCT02229604
Electroacupuncture for Diminished Ovarian Reserve
A Phase 1 study testing EA and HRT, DHEA and herb in people with Irregular Menses, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents and alternative therapy, etc. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Irregular Menses
- What is being tested?
- EA and HRT, DHEA and herb
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2016
- 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age younger than 40 yr
- 10IU/L ≤ FSH ≤ 40IU/L
- Volunteer to join the research and give the informed consent
Who cannot join
- A history of ovariectomy, receiving cytotoxic chemotherapy or irradiation
- Reproductive system infection or tumor
- Autoimmune disease
- Amenorrhea due to reproduction abnormality or pregnancy
- Patients can not adhere to treatment due to personal situation
- Patients have taken immunosuppressive agents in past 6 months
- receive treatment for less than 1 week before withdrawal
About this study
Official title: Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study
Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH) and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect of EA versus other therapies for DOR.
- Conditions
- Irregular Menses
- Being tested
- EA, HRT, DHEA and herb
- Keywords
- electroacupuncture, diminished ovarian reserve, cohort study
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAOther
Also called acupuncture
For BL33, insert the needle to the third posterior sacral foramina to a depth of 80-100mm. For ST25, EX-CA1 and RN4, the needle will be inserted vertically and quickly through the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall (until the moment of resistance is sensed on the tip of the needle and the participant feels a sting). The electric stimulator will be put on the BL33 and EX-CA1 with a continuous wave, 20 Hz, 1.0-4.0 mA.
HRT, DHEA and herbDrug
HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group. Time frame of treatment is not fixed. Herb decoction will be given to participants based on the principle of syndrome differentiation (a diagnosing method in Traditional Chinese Medicine).
| Study group | Role | What they receive |
|---|---|---|
| EA group | Experimental | Patients choose this group will receive EA as a combination. Beside of EA, participants could receive oral medicine as the same as that of the drug group. The EA regimen has two point formulae, i.e. A (BL33) and B (ST25, EX-CA1 and RN4). The two formulae will be used alternatively. One session will last for 20 minutes, 5 sessions per week for the first 4 weeks and 3 sessions per week later (44 sessions in all). Receives: Other: EA; Drug: HRT, DHEA and herb |
| drug group | Active comparator | Hormone replacement therapy (HRT), DHEA and herb decoction are allowed to be used for this group. Treatment course is not fixed. Immunosuppressive agents are not allowed. Receives: Drug: HRT, DHEA and herb |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of FSH from baseline
The follicle-stimulating hormone (FSH) will be tested at baseline and week 12
Measured: baseline, week 12
Secondary outcomes (4)
change of FSH level from baseline
FSH will be tested at baseline and week 4, 8, 16, 20, and 24
Measured: baseline, week 4, 8, 16, 20, and 24
changes in FSH/LH ratio, LH, and E2 from baseline
FSH/LH ratio, LH, and E2 will be tested at baseline and week 4, 8, 12, 16, 20, and 24
Measured: baseline, week 4, 8, 12, 16, 20, and 24
change of symptom scale
Symptoms need to be assessed include irritability and depression. A 4-point scale is used to evaluate the degree of symptoms (0 means "not at all" and 3 means "severe").
Measured: baseline, week 12, week 24
proportion of patients regaining regular menses
The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups
Measured: baseline, weeks 8, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irregular MensesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Ph.D, Study chair, Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229604
- Sponsor's protocol ID
- ZZ0708081
- Status last verified
- Oct 2016
- First submitted
- 25 Aug 2014
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wang Y, Li Y, Chen R, Cui X, Yu J, Liu Z. Electroacupuncture for reproductive hormone levels in patients with diminished ovarian reserve: a prospective observational study. Acupunct Med. 2016 Oct;34(5):386-391. doi: 10.1136/acupmed-2015-011014. Epub 2016 May 13.
PubMed 27177929
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study
- ClinicalTrials.gov ID
- NCT02229604
- Acronym / sponsor ID
- ZZ0708081
- Conditions
- Irregular Menses
- Keywords
- electroacupuncture, diminished ovarian reserve, cohort study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Sep 2014 (estimated)
- 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.
Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH) and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect of EA versus other therapies for DOR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA group | Experimental | Other: EA, Drug: HRT, DHEA and herbPatients choose this group will receive EA as a combination. Beside of EA, participants could receive oral medicine as the same as that of the drug group. The EA regimen has two point formulae, i.e. A (BL33) and B (ST25, EX-CA1 and RN4). The two formulae will be used alternatively. One session will last for 20 minutes, 5 sessions per week for the first 4 weeks and 3 sessions per week later (44 sessions in all). |
| drug group | Active comparator | Drug: HRT, DHEA and herbHormone replacement therapy (HRT), DHEA and herb decoction are allowed to be used for this group. Treatment course is not fixed. Immunosuppressive agents are not allowed. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age younger than 40 yr
- 10IU/L ≤ FSH ≤ 40IU/L
- Volunteer to join the research and give the informed consent
Key exclusion criteria (7 listed)
- A history of ovariectomy, receiving cytotoxic chemotherapy or irradiation
- Reproductive system infection or tumor
- Autoimmune disease
- Amenorrhea due to reproduction abnormality or pregnancy
- Patients can not adhere to treatment due to personal situation
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 |
|---|---|---|
| EAAlso: acupunctureFor BL33, insert the needle to the third posterior sacral foramina to a depth of 80-100mm. For ST25, EX-CA1 and RN4, the needle will be inserted vertically and quickly through the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall (until the moment of resistance is sensed on the tip of the needle and the participant feels a sting). The electric stimulator will be put on the BL33 and EX-CA1 with a continuous wave, 20 Hz, 1.0-4.0 mA. | Other | EA group |
| HRT, DHEA and herbHRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group. Time frame of treatment is not fixed. Herb decoction will be given to participants based on the principle of syndrome differentiation (a diagnosing method in Traditional Chinese Medicine). | Drug | EA group, drug group |
Primary outcome
change of FSH from baseline
Time frame: baseline, week 12
The follicle-stimulating hormone (FSH) will be tested at baseline and week 12
4 secondary outcomes
change of FSH level from baseline
Time frame: baseline, week 4, 8, 16, 20, and 24
changes in FSH/LH ratio, LH, and E2 from baseline
Time frame: baseline, week 4, 8, 12, 16, 20, and 24
change of symptom scale
Time frame: baseline, week 12, week 24
proportion of patients regaining regular menses
Time frame: baseline, weeks 8, 12 and 24
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 10 Oct 2016.
- Derived from this study: PubMed 27177929Wang Y, Li Y, Chen R, Cui X, Yu J, Liu Z. Electroacupuncture for reproductive hormone levels in patients with diminished ovarian reserve: a prospective observational study. Acupunct Med. 2016 Oct;34(5):386-391. doi: 10.1136/acupmed-2015-011014. Epub 2016 May 13.
- Individual participant dataSharing planned: Undecided
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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.
Zhishun Liu, Ph.D study chair
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EA and HRT, DHEA and herb in people with Irregular Menses, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 7 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 10 Oct 2016. 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?
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?
change of FSH from baseline (time frame: baseline, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229604, which also lists 1 linked publication.
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 10 Oct 2016.