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

Shandong University of Traditional Chinese Medicine

Status

Completed

Conditions

Infertility

Treatments

Other: Shen Que Moxibustion

Study type

Interventional

Funder types

Other

Identifiers

NCT05653557

SDUTCMSQPOR0113

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

35 to 44 years old

Volunteers

Accepts Healthy Volunteers

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