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

NCT ID: NCT05874518

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-04-30

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).

Conditions

Warm Needling; Electroacupuncture; Ovulation Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

Ask the patient to empty the bladder, and take supine position. Take guanyuan, zhongji, bilateral Tianshu, zigong, guilai, sanyinjiao, Taixi, zusanli, hegu points. Select 0.3mm×40mm fine needles. After conventional disinfection, the needle is 0.5-1 inch deep. Then the 1.5 cm moxa cones were inserted into the tail of the needle of the bilateral sanyinjioa and zusnli points for moxibustion. At the same time, electroacupuncture therapy was used. Select the density wave and set the time for 25 minutes.

Generally, the patient feels comfortable as moderate, so that the patient feel acid, distension, heat or local muscles for rhythmic contraction. After treatment, first reduce the power to zero value, turn off the power supply, then remove the electrode clip from the needle handle, and pull out the fine needle stabbed into the tissue. 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.

Group Type: EXPERIMENTAL

warm needling combined with electroacupuncture

Intervention Type: OTHER

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.

Control group

Treatment was started on day 5 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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Liuzhou Maternity and Child Healthcare Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fanghua Yang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fanghua Yang

Liuzhou, Guangxi, China

Countries

China

Other Identifiers

LiuzhouMCHH

Identifier Type: -

Identifier Source: org_study_id