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Poor Ovarian ResponsePORNCT03994614

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

A study testing TEAS in people with Poor Ovarian Response, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 45 years, women only
Conditions the study is for
Poor Ovarian Response
What is being tested?
TEAS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
1 Jan 2020to 1 May 2021
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 20 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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）

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
TEAS
Keywords
transcutaneous electrical acupoint stimulation, quality of oocyte, ovarian reserve, poor ovarian response, in vitro fertilization-embryo transfer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEASOther

    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).

Study groups in NCT03994614
Study groupRoleWhat they receive
the TEAS intervention groupExperimentalPatients in this group will be given TEAS treatment for 12 weeks prior to COS.
Receives: Other: TEAS
No intervention groupNo interventionPatients in this group will not be given any interventions for 12 weeks prior to COS.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of MII eggs

    The number of MII eggs obtained in the COS cycle

    Measured: one day after oocyte pickup

Secondary outcomes (10)

  1. Basic Follicle stimulating hormone （FSH） value

    Basic FSH value in mIU/ml

    Measured: On Day two of menstruation

  2. Basic Luteinizing hormone （LH） value

    Basic LH in mIU/ml

    Measured: On Day two of menstruation

  3. Basic estrodiol value

    Basic estrodiol in pg/ml

    Measured: On Day two of menstruation

  4. Serum AMH value

    Serum AMH in ng/ml

    Measured: On Day two of menstruation

  5. antral follicle count

    antral follicle count

    Measured: antral follicle count On Day two of menstruation

  6. fertilization rate

    fertilization rate

    Measured: fertilization rate calculated on 1 day after oocyte pickup

  7. cleavage rate

    cleavage rate

    Measured: cleavage rate calculated on 2 days after oocyte pickup

  8. the number of Day 3 embryos

    the number of Day 3 embryos

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

  9. clinical pregnancy rate

    clinical pregnancy rate

    Measured: clinical pregnancy rate calculated on the 6th gestational week

  10. early abortion rate

    early abortion rate

    Measured: early abortion rate calculated on 12th week of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start1 Jan 2020
  3. Primary completion1 May 2021
  4. Study completion1 May 2021

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03994614
Sponsor's protocol ID
JIAI 2019-4
Acronym
POR
Status last verified
Mar 2022
First submitted
2 Apr 2019
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TEAS in people with Poor Ovarian Response, run by ShangHai Ji Ai Genetics & IVF Institute 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 2 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 8 Apr 2022. 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. 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?

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?

The number of MII eggs (time frame: one day after oocyte pickup). 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 NCT03994614.

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 8 Apr 2022.

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