Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve

Diminished Ovarian Reserve Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972877
• Other study ID #: TJ-IRB20190620
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: December 2025

Study information

• Verified date: July 2021
• Source: Huazhong University of Science and Technology
• Contact: Dongmei Huang, doctor
• Phone: 13971578190
• Email: hdmjcr[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In this trial, we hypothesize that electro-acupuncture is efficient for the ovarian function and the following outcome of IVF-ET in DOR patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Age < 40, will undergo IVF-ET;

2. 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;

3. Spouse' semen examination is normal, or after semen prewash can reach the standard of common IVF or Intracytoplasmic Sperm Injection(ICSI).

Exclusion Criteria:

1. Male with azoospermia;

2. Male/female's chromosome is abnormal;

3. Adenomyosis, uterine fibroids, endometrial polyps, scar uterine, reproductive system tuberculosis, oviduct effusion, pelvic lesions such as ovarian endometriosis cyst or tumor;

4. Female has other endocrine disease: thyroid diseases, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.

5. Definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome;

6. Other pathogenesis that leads to recurrent miscarriage or agnogenic recurrent miscarriage;

7. A history of cancer and has received radiotherapy and chemotherapy;

8. Had acupuncture treatment in recent 3 months;

9. Unwilling to sign the informed consent of this study.

Related Conditions & MeSH terms

• Diminished Ovarian Reserve

Intervention

Other:
• Treatment group protocol
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 protocol
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.

Locations

Country	Name	City	State
China	Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (6)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Edwatz Medical Research Institude, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine, Wuhan No.1 Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 week and up to 4 weeks
Secondary	Clinical pregnancy rate	the clinical pregnancy rate per cycle of IVF-ET after electro-acupuncture.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	0 week and up to 12 weeks
Secondary	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-?) : 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).	0 week and up to 4 weeks
Secondary	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.	through study completion, an average of 1 year