Effect of Acupuncture Plus Governor Vessel Moxibustion Combined With Letrozole on Live Birth in A… (NCT04987632) | Clinical Trial Compass
UnknownPhase 1
Effect of Acupuncture Plus Governor Vessel Moxibustion Combined With Letrozole on Live Birth in Anovulatory Infertile Women With Spleen-kidney Yang Deficiency PCOS
90 participantsStarted 2021-08-03
Plain-language summary
Investigators expected to verify this hypothesis through this study:acupuncture and moxibustion combined with LE induced ovulation in Chinese anovulatory PCOS women has a higher rate of live birth than LE induced ovulation alone.
Who can participate
Age range20 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women between the ages of 20 and 40.
* It meets the diagnostic criteria of spleen-kidney Yang deficiency type PCOS.
* According to World Health Organization standards (2010), the husband's semen analysis meets ①or ②.①Sperm density ≥15×10\^6/ml, and motile sperm (forward and non-forward) ≥40% (A + B + C ≥40%)).② Total motile sperm number ≥9 million.That is, the percentage of semen volume × semen density × motility sperm ≥9×10\^6.
* Tubal patency tests, including hysterosalpingography and diagnostic laparoscopy, which show that at least one fallopian tube is open.(If there is no history of pelvic operation or abortion, patency test results are effective within 3 years;If there is a history of fertility within 5 years and there is no pelvic operation, the tubal patency test is not required).
* Agree to discontinue the use of other therapies during the study. 6) Participate in the study voluntarily and sign the informed consent.
Exclusion Criteria:
* Eliminate other endocrine disorders: ①Patients with hyperprolactinemia (defined as two prolactin levels greater than or equal to 25ng/ml or determined by local standard values at least one week apart).The goal of excluding patients with hyperprolactinemia was to reduce variability among PCOS patients.These patients may be treated with alternative therapies (e.g., dopamine agonists).Those who had received treatment within the past year or were receiving treatment with normal test values could be enrolled. ② …
What they're measuring
1
live birth rate
Timeframe: Within 1 year after the end of Cycle 4 (each cycle is 28 days).
2
Clinical pregnancy rate
Timeframe: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).