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

NCT05653557 | Completed DMC

• 1 other identifier: SDUTCMSQPOR0113
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  Number of oocytes retrieved

  One month

Secondary Outcomes (6)

• Cycle cancellation rate

  One month

• Number of Metaphase II (MII) eggs

  One month

• Cumulative Clinical pregnancy rate

  Fourteen months

• Implantation rate

  Fourteen months

• Good quality embryo rate

  One month

Study Arms (2)

Shen Que Moxibustion group

EXPERIMENTAL

Other: Shen Que Moxibustion

Control group

NO INTERVENTION

Interventions

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.

Shen Que Moxibustion group

Eligibility Criteria

• Age: 35 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University of Traditional Chinese Medicine: lead

Study Sites (1)

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250014, China

Location

Related Publications (1)

• Song JY, Sun ZG, Ma YX. Efficacy and safety of Shen Que (RN8) moxibustion on reproductive outcomes in unexpected poor ovarian responders: a randomized controlled trial. J Ovarian Res. 2024 Aug 29;17(1):177. doi: 10.1186/s13048-024-01493-2.

  PMID: 39210342 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: January 1, 2022
• Primary Completion: November 10, 2023
• Study Completion: December 15, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

CN (1)