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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-15

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.

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shen Que Moxibustion group

Group Type EXPERIMENTAL

Shen Que Moxibustion

Intervention Type 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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Shen 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.

Intervention Type OTHER

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes