Diminished Ovarian ReserveNCT04972877
Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve
A study testing Treatment group protocol in people with Diminished Ovarian Reserve, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian function. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- Treatment group protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2019to Dec 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age < 40, will undergo IVF-ET;
- Low ovarian reserve: Antral follicle count (AFC)<7, or AMH<1.1ng/ml; or has a history of poor ovarian response: in the last hyper stimulation cycle, the number of retrieved oocytes<3;
- Spouse' semen examination is normal, or after semen prewash can reach the standard of common IVF or Intracytoplasmic Sperm Injection(ICSI).
Who cannot join
- Male with azoospermia;
- Male/female's chromosome is abnormal;
- Adenomyosis, uterine fibroids, endometrial polyps, scar uterine, reproductive system tuberculosis, oviduct effusion, pelvic lesions such as ovarian endometriosis cyst or tumor;
- Female has other endocrine disease: thyroid diseases, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
- Definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome;
- Other pathogenesis that leads to recurrent miscarriage or agnogenic recurrent miscarriage;
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- A history of cancer and has received radiotherapy and chemotherapy;
- Had acupuncture treatment in recent 3 months;
- Unwilling to sign the informed consent of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
Wuhan, Hubei, 027
Dongmei Huang, 13971578190, hdmjcr@qq.com
About this study
Official title: Effect of Electro-acupuncture on Ovarian Function and Outcome of IVF-ET of Women With Diminished Ovarian Reserve：a Randomized Controlled Clinical Trial
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian function. In this trial, we hypothesize that electro-acupuncture is efficient for the ovarian function and the following outcome of IVF-ET in DOR patients.
Read the detailed description
First, patients will be recruited according to the inclusion criteria and exclusion criteria.
Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life) will be taken.
Third, each patient will receive 24 sessions of acupuncture in 2-3 months, twice or three times a week.
Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
- Conditions
- Diminished Ovarian Reserve
- Being tested
- Treatment group protocol, Control group protocol
- Keywords
- Electro-acupuncture, Diminished ovarian reserve, In vitro fertilization-embryo transfer, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment group protocolOther
For treatment group, two groups of acupoints will be used alternatively. The first group consists of some acupoints. The patients will be asked to stay in supine position. Disposable sterilized needles (Size: 0.25*40/50 mm) will be inserted into a depth of 15~35 mm and stimulated manually to evoke needle sensation. And then some acupoints will be thereafter connected to electrical stimulators and stimulated with low-frequency and the maximum tolerated intensity of the patients. The other needles without electrical stimulators will be manually stimulated to evoke "Deqi" every 10 minutes.
The second group consists of other acupoints. Patients will be asked to stay in prone position. The stimulation will be in the same way as the first group.
Control group protocolOther
For control group, four pseudo-acupoints are used, with two points on each shoulder and the two on each upper arm, which are not located on any meridians. The patients will be asked to stay in supine position and keep the whole body relaxed and comfortable. Disposable sterilized needles (Size: 0.18*25 mm) will be inserted superficially to a depth of < 5 mm without any manual stimulus and the needle sensation ("Deqi" in TCM) should not be evoked. Electrodes are connected to the needles, but the stimulators should be turned on at an intensity of zero. Each intervention lasts for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Treatment group protocol：participants will receive electro-acupuncture twice or three times a week with a maximum of 24 times in 2-3 months. Each treatment session lasts for 30 minutes. Receives: Other: Treatment group protocol |
| Control group | Sham comparator | Control group protocol：participants will receive sham electro-acupuncture twice or three times a week with a maximum of 24 times in 2-3 months. Each treatment session lasts for 30 minutes. Receives: Other: Control group protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change of ovarian reserve function
Assessing patients' ovarian reserve function before and after electro-acupuncture intervention, including: (1) The serum AMH, inhibin, and FSH and E2 levels on the third day of menstruation;(2) AFC.
Measured: 0 week and up to 4 weeks
Secondary outcomes (5)
Clinical pregnancy rate
the clinical pregnancy rate per cycle of IVF-ET after electro-acupuncture.
Measured: through study completion, an average of 1 year
Outcomes of IVF
- Gn dosage(U/d) and usage days;
- E2 level(pg/ml) and endometrial thickness(mm) on human chorionic gonadotropin (HCG) day;
- number of oocytes;
- MII oocytes;
- normal fertility rate;
- the number of available embryos;
- number of high-quality embryos;
- cycle cancellation rate (including cycle cancellation rate caused by various reasons);
- implantation rate: including fresh periodic implantation rate, per cycle implantation rate and cumulative implantation rate;
- fresh cycle clinical pregnancy rate and cycle cumulative clinical pregnancy rate;
- early, mid and late pregnancy abortion rate;
- risk of ovarian hypertrophy and incidence of obstetric complications;
- FSH(mIU/ml), LH(mIU/ml), E2(pg/ml) and AMH(ng/ml) in follicular fluid; Oxidative stress related indicators such as reactive oxygen species (ROS), superoxide dismutase (SOD) level, etc.;
- live rate: including fresh cycle live rate, cycle live rate and cumulative live rate.
Measured: through study completion, an average of 1 year
Blood biochemical index examination
Testing the levels of blood corticotrophin-releasing hormone (CRH), norepinephrine, adrenaline, 5-hydroxytryptamine, beta-aminobutyric acid (GABA), dopamine (DA) and neuro-endorphin of the patients before and after treatment.
Measured: 0 week and up to 12 weeks
Questionnaires
Evaluation of anxiety, depression, quality of life and sleep state is performed before and after treatment.
- Baker anxiety self-rating scale (BAI) and baker depression self-rating scale (BDI-Ⅱ) : higher score indicates higher degree of depression or anxiety [12-13].
- Zung anxiety self-rating scale (Zung-SAS), Zung depression self-rating scale (Zung-SDS) [14-15].
- Quality of life measurement (QOL): Quality of life will be assessed by SF-36 and Chinese quality of life scale (CHQOL).
- Self-Rating Scale of Sleep (SRSS), sleep dysfunction rating scale (SDRS), Pittsburgh sleep quality index (PSQI).
Measured: 0 week and up to 4 weeks
Follow-up detection
Pregnancy patients will be followed up to the end of pregnancy. Adverse pregnancy outcomes and live birth rates will be recorded. Non-pregnant patients will be followed up for 1 year after treatment, testing the ovarian reserve function, follow-up treatment and pregnancy status of the patients within 1 year.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start9 Sep 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan No.1 Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Edwatz Medical Research Institude, Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine
- Responsible party
- Principal investigator, Dongmei Huang, Huazhong University of Science and Technology
- Investigators
- Dongmei Huang, doctor, Principal investigator, Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972877
- Sponsor's protocol ID
- TJ-IRB20190620
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we use the Clinical Trial Management Public Platform to manage and share our date.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electro-acupuncture on Ovarian Function and Outcome of IVF-ET of Women With Diminished Ovarian Reserve：a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04972877
- Acronym / sponsor ID
- TJ-IRB20190620
- Conditions
- Diminished Ovarian Reserve
- Keywords
- Electro-acupuncture, Diminished ovarian reserve, In vitro fertilization-embryo transfer, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan No.1 Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Edwatz Medical Research Institude, Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jul 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.
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian function. In this trial, we hypothesize that electro-acupuncture is efficient for the ovarian function and the following outcome of IVF-ET in DOR patients.
Detailed description
First, patients will be recruited according to the inclusion criteria and exclusion criteria.
Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life) will be taken.
Third, each patient will receive 24 sessions of acupuncture in 2-3 months, twice or three times a week.
Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Other: Treatment group protocolTreatment group protocol：participants will receive electro-acupuncture twice or three times a week with a maximum of 24 times in 2-3 months. Each treatment session lasts for 30 minutes. |
| Control group | Sham comparator | Other: Control group protocolControl group protocol：participants will receive sham electro-acupuncture twice or three times a week with a maximum of 24 times in 2-3 months. Each treatment session lasts for 30 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age < 40, will undergo IVF-ET;
- Low ovarian reserve: Antral follicle count (AFC)<7, or AMH<1.1ng/ml; or has a history of poor ovarian response: in the last hyper stimulation cycle, the number of retrieved oocytes<3;
- Spouse' semen examination is normal, or after semen prewash can reach the standard of common IVF or Intracytoplasmic Sperm Injection(ICSI).
Key exclusion criteria (9 listed)
- Male with azoospermia;
- Male/female's chromosome is abnormal;
- Adenomyosis, uterine fibroids, endometrial polyps, scar uterine, reproductive system tuberculosis, oviduct effusion, pelvic lesions such as ovarian endometriosis cyst or tumor;
- Female has other endocrine disease: thyroid diseases, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
- Definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome;
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 |
|---|---|---|
| Treatment group protocolFor treatment group, two groups of acupoints will be used alternatively. The first group consists of some acupoints. The patients will be asked to stay in supine position. Disposable sterilized needles (Size: 0.25*40/50 mm) will be inserted into a depth of 15~35 mm and stimulated manually to evoke needle sensation. And then some acupoints will be thereafter connected to electrical stimulators and stimulated with low-frequency and the maximum tolerated intensity of the patients. The other needles without electrical stimulators will be manually stimulated to evoke "Deqi" every 10 minutes. The second group consists of other acupoints. Patients will be asked to stay in prone position. The stimulation will be in the same way as the first group. | Other | Treatment group |
| Control group protocolFor control group, four pseudo-acupoints are used, with two points on each shoulder and the two on each upper arm, which are not located on any meridians. The patients will be asked to stay in supine position and keep the whole body relaxed and comfortable. Disposable sterilized needles (Size: 0.18*25 mm) will be inserted superficially to a depth of < 5 mm without any manual stimulus and the needle sensation ("Deqi" in TCM) should not be evoked. Electrodes are connected to the needles, but the stimulators should be turned on at an intensity of zero. Each intervention lasts for 30 minutes. | Other | Control group |
Primary outcome
Assessing the change of ovarian reserve function
Time frame: 0 week and up to 4 weeks
Assessing patients' ovarian reserve function before and after electro-acupuncture intervention, including: (1) The serum AMH, inhibin, and FSH and E2 levels on the third day of menstruation;(2) AFC.
5 secondary outcomes
Clinical pregnancy rate
Time frame: through study completion, an average of 1 year
Outcomes of IVF
Time frame: through study completion, an average of 1 year
Blood biochemical index examination
Time frame: 0 week and up to 12 weeks
Questionnaires
Time frame: 0 week and up to 4 weeks
Follow-up detection
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: Yes. we use the Clinical Trial Management Public Platform to manage and share our date.
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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.
Dongmei Huang, doctor principal investigator
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group protocol in people with Diminished Ovarian Reserve, run by Huazhong University of Science and Technology 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 3 inclusion and 9 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 22 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Huang, doctor (13971578190 ext. 02783663275, hdmjcr@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change of ovarian reserve function (time frame: 0 week and up to 4 weeks). 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 22 Jul 2021.