Clinical trial NCT05653557: Efficacy and Safety of Shen Que (RN8) Moxibustion in Unexpected POR
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Shen Que (RN8)
Moxibustion
In Vitro Fertilization and Embryo Transfer (IVF-ET)
Poor Ovarian Response (POR)
Poseidon Criteria
Lead sponsor: Shandong University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: One month
Secondary outcomes:
measure: Cycle cancellation rate
timeFrame: One month
measure: Number of Metaphase II (MII) eggs
timeFrame: One month
measure: Cumulative Clinical pregnancy rate
timeFrame: Fourteen months
measure: Implantation rate
timeFrame: Fourteen months
measure: Good quality embryo rate
timeFrame: One month
measure: Cumulative live birth rate
timeFrame: Eighteen months
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
Study officials:
References: