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Completed

NCT Number: NCT05874518

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

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

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Key information

Conditions

Warm Needling Electroacupuncture Ovulation Dysfunction

Age range

23 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fanghua Yang

Liuzhou, Guangxi, 545001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

warm needling combined with electroacupuncture

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.

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

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.

Primary outcomes

  1. Ultrasound characteristics of ovulation

    Time frame: About 10 days on average until ≥18mm follicle disappears or 20mm follicle volume decreases

    Monitoring follicular intima thickness

  2. vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation

    Time frame: the endometrium of ≥8mm on the fifth day of menstruation

    vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation

  3. Use vaginal B-ultrasound to monitor follicles (size and discharge) and endometrial thickness on the fifth day of menstruation

    Time frame: 48 hours after chorionic gonadotropin injection

    When the follicle size reached 18mm and Chorionic gonadotrophin was injected

  4. Pregnancy judgment

    Time frame: 14 days after ovulation

    Pregnancy was determined by detecting serum HCG (human chorionic gonadotropin) 14 days after ovulation

  5. Pregnancy judgment

    Time frame: about 50 days of pregnancy

    At about 50 days of pregnancy, pregnancy sac or fetal heart beat through vaginal B ultrasound

Sponsors and collaborators

Lead sponsor

Liuzhou Maternity and Child Healthcare Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 25, 2023
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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