CClinicalTrials.gg
CompletedNCT05653557Updated Jan 9, 2024

Efficacy and Safety of Shen Que (RN8) Moxibustion in Unexpected POR

An interventional study of Shen Que Moxibustion in Infertility, sponsored by Shandong University of Traditional Chinese Medicine. Completed at 1 site in China. Open to female participants aged 35 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Shandong University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jan 2022, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years to 44 Years
Sex
Female
01

Study summary

Moxibustion of Shen Que (RN8) can increase the number of embryos available for transfer, thus improving pregnancy outcomes in women of advanced reproductive age who experience unexpected poor ovarian response.

Read the detailed description

According to the traditional Chinese medicine (TCM) theory, Shen Que (RN8) is the place where the vitality converges under the navel, and is closely connected with the vitality generated by the kidney Qi. Therefore, stimulating Shen Que may stimulate the essence stored in the kidney, and improve the fertility of "五七" (≥ 35 years old) women.

Shen Que moxibustion has been shown to improve ovarian functional reserve in patients with ovarian insufficiency in previous studies. Nevertheless, studies on Shen Que moxibustion in advanced women with unexpected poor ovarian response (POR) who undergo IVF-ET are very limited. Consequently, we designed this randomized controlled trial to validate the hypothesis that Shen Que moxibustion improves reproductive outcomes in unexpected POR women.

02

Conditions studied

  • Infertility

Browse trials for

Keywords

  • Shen Que (RN8)
  • Moxibustion
  • In Vitro Fertilization and Embryo Transfer (IVF-ET)
  • Poor Ovarian Response (POR)
  • Poseidon Criteria
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Shandong University of Traditional Chinese Medicine is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • ≥35 years old with normal pre-stimulation ovarian reserve parameters (antral follicle count (AFC) ≥ 5 or anti-mullerian hormone (AMH) ≥1.2 ng/ml) and with an expected poor ovarian response (fewer than 4 oocytes) after standard ovarian stimulation.

Exclusion criteria

Exclusion Criteria:

  • Individuals with a Body Mass Index (BMI) ≥ 35 Kg/m2
  • Those using the natural cycle or mild stimulation for IVF/intracytoplasmic sperm injection (ICSI) treatment
  • Those with a history of unilateral oophorectomy or recurrent pregnancy loss, defined as two or more spontaneous abortions
  • Acceptors of donated oocytes or performed either In vitro Maturation (IVM) or blastocyst biopsy for Preimplantation Genetic Diagnosis (PGD) or Preimplantation Genetic Testing for Aneuploidies (PGT-A)
  • Those previously diagnosed with congenital (e.g., mediastinal uterus and double uterus) or acquired (e.g., submucosal myoma and adenomyosis) uterine abnormalities
  • Patients with extremely advanced age ( ≥ 45 years old)
  • Presence of a non-surgically treated hydrosalpinx or endometrial polyp and an ovarian endometriosis cyst requiring surgery, during ovarian stimulation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Shen Que Moxibustion group

    Other: Shen Que Moxibustion

  • No intervention
    Control group

Interventions

  • OtherShen Que Moxibustion

    Herb-partitioned moxibustion was administered at RN8 (Shen Que), once every 72 hours from the beginning of previous menstrual cycle day 2 until oocyte retrieval. Approximately 10 moxa cones will be used for this procedure, which will take approximately two hours. It is recommended that patients close their eyes during the procedure and rest. Following moxibustion, the umbilicus will be affixed and sealed with a medical applicator and removed after 24 hours.

06

What researchers measure

Primary outcomes

  1. Number of oocytes retrieved

    Number of oocytes retrieved

    Time frame: One month

Secondary outcomes

  1. Cycle cancellation rate

    Cycle cancellation is defined as cycle cancelled before obtaining at least one viable embryo for any reason. And cycle cancellation rate is calculated by dividing the number of women cancelled their cycle before obtaining at least one viable embryo for any reason by the total number of women randomized to the specific group.

    Time frame: One month

  2. Number of Metaphase II (MII) eggs

    MII eggs is defined as eggs retrieved that reach the MII phase.

    Time frame: One month

  3. Cumulative Clinical pregnancy rate

    Clinic pregnancy will be diagnosed with the detection of an intrauterine gestation sac. And cumulative clinic pregnancy rate is calculated by the number of women who achieves clinical pregnancy after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.

    Time frame: Fourteen months

  4. Implantation rate

    Number of gestation sac detected / number of embryo transferred.

    Time frame: Fourteen months

  5. Good quality embryo rate

    Good quality embryo is defined as embryo that is graded as 6-cell grade 2 (6CII) or better or blastocyst. And good quality embryo rate is calculated by dividing the number of good quality embryo by the total number of embryo obtained after fertilization in the specific group.

    Time frame: One month

  6. Cumulative live birth rate

    Cumulative live birth rates (CLBR), defined as the proportion of deliveries with at least one live birth per started cycle or per oocyte aspiration, including all fresh and/or frozen embryo transfers until one delivery with a live birth or until all embryos were used.

    Time frame: Eighteen months

07

Study locations

1 site
  • The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    Jinan, Shandong 250014, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05653557
Lead sponsor
Shandong University of Traditional Chinese Medicine
Responsible party
Jing-Yan Song (Clinical Professor, Shandong University of Traditional Chinese Medicine) — Principal investigator
First posted
Dec 16, 2022
Start date
Jan 1, 2022
Primary completion
Nov 10, 2023
Completion
Dec 15, 2023
Last update
Jan 9, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion