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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Shen Que Moxibustion

• Registration Number: NCT05653557
• Lead Sponsor: Shandong University of Traditional Chinese Medicine

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.

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-16
• Primary Completion: 2023-11-10
• Study Completion: 2023-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-07
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shen Que Moxibustion group	Shen Que Moxibustion	-

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	One month	Number of oocytes retrieved

Secondary Outcome Measures

Name	Time	Method
Cumulative Clinical pregnancy rate	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.
Cumulative live birth rate	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.
Cycle cancellation rate	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.
Implantation rate	Fourteen months	Number of gestation sac detected / number of embryo transferred.
Good quality embryo rate	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.
Number of Metaphase II (MII) eggs	One month	MII eggs is defined as eggs retrieved that reach the MII phase.

Trial Locations

Locations (1)

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, Shandong, China