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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Other: Shen Que Moxibustion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shen Que Moxibustion group<br> | Other: Shen Que Moxibustion<br>* Herb-partitioned moxibustion was administered at RN8 (Shen Que), once every 72 hours from the beginning of ovarian stimulation until embryo transfer. 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Eighteen months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One month | 
| Number of Metaphase II (MII) eggs | MII eggs is defined as eggs retrieved that reach the MII phase. | One month | 
| 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. | Fourteen months | 
| Implantation rate | Number of gestation sac detected / number of embryo transferred. | Fourteen months | 
| 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. | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poseidon Criteria, Shen Que (RN8), Moxibustion, In Vitro Fertilization and Embryo Transfer (IVF-ET), Poor Ovarian Response (POR)