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NCT Number: NCT05653557

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

35 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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

Treatment and study plan

Shen Que Moxibustion

Other

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.

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: One month

    Number of oocytes retrieved

Secondary outcomes

  1. Cycle cancellation rate

    Time frame: One month

    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.

  2. Number of Metaphase II (MII) eggs

    Time frame: One month

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

  3. Cumulative Clinical pregnancy rate

    Time frame: Fourteen months

    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.

  4. Implantation rate

    Time frame: Fourteen months

    Number of gestation sac detected / number of embryo transferred.

  5. Good quality embryo rate

    Time frame: One month

    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.

  6. Cumulative live birth rate

    Time frame: Eighteen months

    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.

Sponsors and collaborators

Lead sponsor

Shandong University of Traditional Chinese Medicine

Other

Registry information

Official study title

Efficacy and Safety of Shen Que (RN8) Moxibustion on Reproductive Outcomes in Women of Advanced Reproductive Age (≥35 Years Old) With Unexpected Ovarian Poor Ovarian Response Undergoing in Vitro Fertilization and Embryo Transfer (IVF-ET): a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2022
Registry last updated
Jan 9, 2024

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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