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Completed

NCT Number: NCT02229604

Electroacupuncture for Diminished Ovarian Reserve

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.

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Key information

Conditions

Irregular Menses Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age younger than 40 yr
  • 10IU/L ≤ FSH ≤ 40IU/L
  • Volunteer to join the research and give the informed consent

Exclusion criteria

  • 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

Treatment and study plan

EA

Other

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.

Other names: acupuncture

HRT, DHEA and herb

Drug

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).

Primary outcomes

  1. change of FSH from baseline

    Time frame: baseline, week 12

    The follicle-stimulating hormone (FSH) will be tested at baseline and week 12

Secondary outcomes

  1. change of FSH level from baseline

    Time frame: baseline, week 4, 8, 16, 20, and 24

    FSH will be tested at baseline and week 4, 8, 16, 20, and 24

  2. changes in FSH/LH ratio, LH, and E2 from baseline

    Time frame: baseline, week 4, 8, 12, 16, 20, and 24

    FSH/LH ratio, LH, and E2 will be tested at baseline and week 4, 8, 12, 16, 20, and 24

  3. change of symptom scale

    Time frame: baseline, week 12, week 24

    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").

  4. proportion of patients regaining regular menses

    Time frame: baseline, weeks 8, 12 and 24

    The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2014
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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