Back to resultsEfficacy and Safety of Shen Que (RN8) Moxibustion in Unexpected POR
Primary Purpose
Infertility
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Shen Que Moxibustion
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Shen Que (RN8), Moxibustion, In Vitro Fertilization and Embryo Transfer (IVF-ET), Poor Ovarian Response (POR), Poseidon Criteria
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
Sites / Locations
- The Affiliated Hospital of Shandong University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Shen Que Moxibustion group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Number of Metaphase II (MII) eggs
MII eggs is defined as eggs retrieved that reach the MII phase.
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.
Implantation rate
Number of gestation sac detected / number of embryo transferred.
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.
Full Information
NCT ID
NCT05653557
First Posted
December 8, 2022
Last Updated
February 14, 2023
Sponsor
Shandong University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05653557
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Shen Que (RN8), Moxibustion, In Vitro Fertilization and Embryo Transfer (IVF-ET), Poor Ovarian Response (POR), Poseidon Criteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shen Que Moxibustion group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Shen Que Moxibustion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative live birth rate
Description
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.
Time Frame
Eighteen months
Secondary Outcome Measure Information:
Title
Cycle cancellation rate
Description
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.
Time Frame
One month
Title
Number of Metaphase II (MII) eggs
Description
MII eggs is defined as eggs retrieved that reach the MII phase.
Time Frame
One month
Title
Cumulative Clinical pregnancy rate
Description
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.
Time Frame
Fourteen months
Title
Implantation rate
Description
Number of gestation sac detected / number of embryo transferred.
Time Frame
Fourteen months
Title
Good quality embryo rate
Description
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.
Time Frame
One month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-Yan Song, M.D
Phone
+8618765800113
Email
hanlingjuzei91@126.com
Facility Information:
Facility Name
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen-Gao Sun, PhD
Phone
+8613708938621
Email
sunzhengao77@126.com
12. IPD Sharing Statement
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Efficacy and Safety of Shen Que (RN8) Moxibustion in Unexpected POR
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