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

Electroacupuncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874518
• Other study ID #: LiuzhouMCHH
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2023
• Source: Liuzhou Maternity and Child Healthcare Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Electroacupuncture

Intervention

Other:
• warm 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.

Drug:
• The 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.

Locations

Country	Name	City	State
China	Fanghua Yang	Liuzhou	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Liuzhou Maternity and Child Healthcare Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound characteristics of ovulation	Monitoring follicular intima thickness	About 10 days on average until =18mm follicle disappears or 20mm follicle volume decreases
Primary	vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation	vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation	the endometrium of =8mm on the fifth day of menstruation
Primary	Use vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation	When the follicle size reached 18mm and Chorionic gonadotrophin was injected	48 hours after chorionic gonadotropin injection
Primary	Pregnancy judgment	Pregnancy was determined by detecting serum HCG (human chorionic gonadotropin) 14 days after ovulation	14 days after ovulation
Primary	Pregnancy judgment	At about 50 days of pregnancy, pregnancy sac or fetal heart beat through vaginal B ultrasound	about 50 days of pregnancy