The effect of acupuncture pretreatment on the clinical pregnancy rate of IVF-ET in patients with diminished ovarian reserve: a multicenter randomized controlled trial
- Conditions
- diminished ovarian reserve
- Registration Number
- ITMCTR2024000021
- Lead Sponsor
- Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
(1) Meets the criteria for Group 3 and Group 4 of the POSEIDON POR classification criteria;
(2) Female, 20 years = age < 40 years;
(3) Regular menstruation (21-35 days);
(4) Fertility needs, with a proposed IVF/ICSI-ET antagonist or microstimulation regimen to assist conception, and with a proposed transfer of 1-2 high-quality embryos at the cleavage stage or 1 blastocyst;
(5) Voluntarily participate in the trial and sign the informed consent form.
(1) FSH = 25 IU/L;
(2) Diseases related to the reproductive physician's judgment that affect conception (any of the following may be excluded if they do not affect embryo transfer): congenital abnormalities in the development of reproductive organs, untreated endometrial polyps, untreated uterine adhesions, untreated uterine infections, untreated tubal hydrosalpinx, thin endometrium, uterine fibroids (>5 cm, submucosal uterine fibroids), endometriosis, or other organic diseases;
(3) Repeated implantation failures (after at least 3 transfer cycles, fresh or frozen embryo transfer cycles involving the transfer of at least 4 high-quality embryos without pregnancy; or 2 consecutive fresh or frozen transfer cycles and the transfer of at least 4 cleavage-stage embryos or at least 2 high-quality blastocysts without obtaining a clinical pregnancy);
(4) Combination of metabolic endocrine diseases such as uncorrected hyperprolactinemia, hyperandrogenemia, thyroid dysfunction, chronic hypoadrenocorticism, or other metabolic endocrine diseases;
(5) Azoospermia in the male partner;
(6) Those with combined serious cardiovascular, cerebrovascular, hepatic, renal, malignant tumor, hematopoietic system and mental diseases;
(7) Those who have a history of acupuncture treatment;
(8) Recurrent abortion (refers to 2 or more consecutive pregnancy losses with the same spouse that occurred before 28 weeks of gestation, including biochemical pregnancy);
(9) Patients with severe anxiety, i.e., those with a score of >70 on the Self-Rating Anxiety Scale (SAS);
(10) Chromosomal abnormalities and carriers.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical pregnancy rate;
- Secondary Outcome Measures
Name Time Method umber of follicles = 14mm on HCG day, E2 level on HCG day, endometrial thickness on HCG day, number of retrieved eggs, number of MII eggs, number of 2PN and 2PN fertilization rate, available embryo rate, high-quality embryo rate, embryo implantation rate, cycle cancellation rate, biochemical pregnancy rate, early pregnancy loss rate, sustained pregnancy rate, and live birth rate;antral follicular count (AFC), follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), anti Mullerian hormone (AMH);Self-Rating Anxiety Scale;