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Clinical Observation of Warm Needling Combined With and Electroacupuncture Therapy on Ovulatory Dysfunction

Clinical Observation of Warm Needling Combined With and Electroacupuncture Therapy on Ovulatory Dysfunction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05874518
Enrollment
70
Registered
2023-05-25
Start date
2021-12-01
Completion date
2022-04-30
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electroacupuncture, Ovulation Dysfunction, Warm Needling

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).

Interventions

OTHERwarm needling combined with electroacupuncture

Treatment begins on the 5th day of the menstrual cycle, qd (once a day), usually for 6-8 consecutive days, and continuing to the day of ovulation.

DRUGThe treatment with letrozole tablets was started on the fifth day of the menstrual cycle

Letrozole tablets were given at 2.5mg (Jiangsu Hengrui Pharmaceutical Co., Ltd., H19991001, 2.5mg per tablet), po (oral), qd, for 5-7 consecutive days. When the diameter of follicles reaches 18mm, Chorionic gonadotrophin is given at 5000u (Lizhu Group Lizhu Pharmaceutical Factory, Chinese medicine H44020668, 5000u per branch), with intramuscular injection, qd, to promote follicle discharge. Patients were also instructed to have sexual intercourse on the same day and on day 2.

Sponsors

Liuzhou Maternity and Child Healthcare Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
23 Years to 48 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound characteristics of ovulationAbout 10 days on average until ≥18mm follicle disappears or 20mm follicle volume decreasesMonitoring follicular intima thickness
vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruationthe endometrium of ≥8mm on the fifth day of menstruationvaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation
Use vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation48 hours after chorionic gonadotropin injectionWhen the follicle size reached 18mm and Chorionic gonadotrophin was injected
Pregnancy judgment14 days after ovulationPregnancy was determined by detecting serum HCG (human chorionic gonadotropin) 14 days after ovulation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026