Clinical trial NCT05874518: Clinical Observation of Warm Needling Combined With and Electroacupuncture Therapy on Ovulatory Dysfunction
Official title: Clinical Observation of Warm Needling Combined With and Electroacupuncture Therapy on Ovulatory Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warm Needling
Electroacupuncture
Ovulation Dysfunction
Lead sponsor: Liuzhou Maternity and Child Healthcare Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 70
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To observe the effect of warm needling combined with electroacupuncture on the ovulation promotion rate and pregnancy rate in luteinized unruptured follicle syndrome (LUFS).


Eligibility criteria: Inclusion Criteria:

* Infertility diagnosis criteria refer to the "Obstetrics and Gynecology" \[10\]: Infertility refers to the patient fails to conceive a pregnancy with normal sexual life and without contraception for 1 year. In primary infertility, pregnancy has never occurred. In secondary infertility, patients have previously conceived, but are unable to conceive again without contraception for 1 year.
* The standard for ovulation infertility is formulated according to the first series of Guiding Principles for Clinical Research of New Chinese Medicine: Basal body temperature was continuously recorded for single phase for more than 3 months; Vaginal detached cell smear examination showed no significant periodic changes; Cervical mucus crystallization examination showed no periodic changes, and ellipsoid; There was no typical secretory period change in endometrial examination on 6 days before menstruation; a series of B-ultrasound monitoring showed no ovulation signs; Blood and urinary progesterone levels were lower than those in the luteal phase. Patients who met two of the above 6 items could be diagnosed with anovulation

Exclusion Criteria:

* Those who have any serious adverse reactions during the treatment process and cannot continue the treatment
* Failing to follow the treatment plan and receiving other treatment
* Patients who quit the treatment process by themselves, or who have an incomplete course of treatment, will have a negative effect on the curative effect

Primary outcomes:
measure: Ultrasound characteristics of ovulation
timeFrame: About 10 days on average until ≥18mm follicle disappears or 20mm follicle volume decreases
measure: vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
timeFrame: the endometrium of ≥8mm on the fifth day of menstruation
measure: Use vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
timeFrame: 48 hours after chorionic gonadotropin injection
measure: Pregnancy judgment
timeFrame: 14 days after ovulation
measure: Pregnancy judgment
timeFrame: about 50 days of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Fanghua Yang
state: Guangxi
Study officials:
References: