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Completed

NCT Number: NCT03994614

the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of Oocyte on Poor Ovarian Response(POR)

Patients in experimental group will be given transcutaneous electrical acupoint stimulation (TEAS) treatment for 12 weeks prior to controlled ovarian stimulation (COS).The patients will be given three times acupuncture every week except menstruation.Patients in no intervention group will not be given any interventions for 12 weeks prior to COS. The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

About this study

The patients will be randomly recruited into two groups. Patients in experimental group will be given TEAS treatment for 12 weeks prior to COS.The patients will be given three times acupuncture every week except menstruation. One treatment lasts for 30 minutes. The acupoints used for the TEAS treatment included head acupoint Baihui(DU20), abdominal acupoint Zhongji (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu (BL23) and Guanyuanyu(BL26). Patients in no intervention group will not be given any intervention for 12 weeks prior to COS. When at least one dominant follicle is greater than 18 mm then injection a GnRH agonist (Triptorelin, Ferring, Switzerland) 0.2mg. 36 hours later transvaginal oocyte retrieval will be taken. After 3 hours of incubation, each egg will be transferred with a density of about 100,000/mllive sperm. The fresh embryo transfer is performed 72 hours after embryo culture in vitro. The whole embryos will be frozen.

The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes,including basic endocrine, serum Anti-Mullerian Hormone (AMH), antral follicle counts, fertilization rate, cleavage rate, number of D3 embryos, the clinical pregnancy rate and early abortion rate.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The poor ovarian response patients compliance with Bologna consensus
  • Age:20-45 year
  • Women undergoing IVF-ET because of infertility for more than one year.

Exclusion criteria

  • Patients with genital tract malformation. Uterine malformation (single uterus, double uterus, double uterus, untreated mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis, submucosal uterine fibroids, intrauterine adhesions and scar uterus)
  • Complicated with other medical diseases(Hypertension, diabetes, psychosis, hereditary diseases)

Treatment and study plan

TEAS

Other

Patients in the experimental group will be given TEAS treatment for 12 weeks prior to COS. The patients will be given three times acupuncture every week except menstruation. The acupuncture acupoint locations are as follows: head acupoint Baihui(DU20), abdominal acupoint Zhongji (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu (BL23) and Guanyuanyu(BL26).

Primary outcomes

  1. The number of MII eggs

    Time frame: one day after oocyte pickup

    The number of MII eggs obtained in the COS cycle

Secondary outcomes

  1. Basic Follicle stimulating hormone (FSH) value

    Time frame: On Day two of menstruation

    Basic FSH value in mIU/ml

  2. Basic Luteinizing hormone (LH) value

    Time frame: On Day two of menstruation

    Basic LH in mIU/ml

  3. Basic estrodiol value

    Time frame: On Day two of menstruation

    Basic estrodiol in pg/ml

  4. Serum AMH value

    Time frame: On Day two of menstruation

    Serum AMH in ng/ml

  5. antral follicle count

    Time frame: antral follicle count On Day two of menstruation

    antral follicle count

  6. fertilization rate

    Time frame: fertilization rate calculated on 1 day after oocyte pickup

    fertilization rate

  7. cleavage rate

    Time frame: cleavage rate calculated on 2 days after oocyte pickup

    cleavage rate

  8. the number of Day 3 embryos

    Time frame: the number of Day 3 embryos calculated on 3 days after oocyte pickup

    the number of Day 3 embryos

  9. clinical pregnancy rate

    Time frame: clinical pregnancy rate calculated on the 6th gestational week

    clinical pregnancy rate

  10. early abortion rate

    Time frame: early abortion rate calculated on 12th week of pregnancy

    early abortion rate

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study title

The Clinical Trial of the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of the Oocyte on Poor Ovarian Response

Acronym: POR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2019
Registry last updated
Apr 8, 2022

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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