NCT04987632

Brief Summary

Investigators expected to verify this hypothesis through this study:acupuncture and moxibustion combined with LE induced ovulation in Chinese anovulatory PCOS women has a higher rate of live birth than LE induced ovulation alone.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 3, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

July 15, 2021

Last Update Submit

August 2, 2021

Conditions

PCOSInfertility, Female

Keywords

PCOSacupunctureGovernor vessel moxibustionspleen-kidney Yang deficiencyletrozole

Outcome Measures

Primary Outcomes (2)

  • live birth rate

    Ratio of the number ofdelivery of a live-born infant to the total number pregnancies of trials.

    Within 1 year after the end of Cycle 4 (each cycle is 28 days).

  • Clinical pregnancy rate

    Ratio of the number of pregnancies to the total number of trials.

    From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).

Secondary Outcomes (6)

  • Ovulation rate

    From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).

  • Multiple pregnancy rate

    From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).

  • Abortion rate

    From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).

  • HOMA-IR

    Before the trail and at the end of cycle 4.

  • Metabolic blood test

    Before the trail and at the end of cycle 4.

  • +1 more secondary outcomes

Study Arms (2)

Letrozole combined with acupuncture and Du Meridian moxibustion group

EXPERIMENTAL

Letrozole combined with acupuncture and Du Meridian moxibustion was taken from 3-5 days of menstrual period (spontaneous menstruation or progesterone withdrawal bleeding). The acupuncture treatment was 3 times / week, with an interval of 2-4 days, 12 times a week, 30 minutes each time; Du Meridian moxibustion is 20 minutes each time, once a week, four times a week. The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation with acupuncture plus Du Meridian moxibustion.

Drug: LetrozoleDevice: acupunctureOther: Governor vessel moxibustion

Letrozole group

ACTIVE COMPARATOR

Letrozole was taken 3-5 days after menstruation (spontaneous menstruation or progesterone withdrawal bleeding). The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. In the absence of pregnancy, subjects were treated with letrozole for up to four cycles.

Drug: Letrozole

Interventions

LetrozoleDRUG

Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.

Letrozole combined with acupuncture and Du Meridian moxibustion groupLetrozole group
acupunctureDEVICE

Domestic and foreign studies suggest that acupuncture and electroacupuncture can improve the menstrual cycle of PCOS and reduce the level of total testosterone; Acupuncture can regulate glucose homeostasis by stimulating the autonomic nervous system of PCOS patients. Our previous studies and a large number of literatures have proved that acupuncture can improve insulin resistance in PCOS, and acupuncture can improve the pregnancy rate in PCOS.

Letrozole combined with acupuncture and Du Meridian moxibustion group
Governor vessel moxibustionOTHER

It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation

Letrozole combined with acupuncture and Du Meridian moxibustion group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women between the ages of 20 and 40.
  • It meets the diagnostic criteria of spleen-kidney Yang deficiency type PCOS.
  • According to World Health Organization standards (2010), the husband's semen analysis meets ① or ②.①Sperm density ≥15×10\^6/ml, and motile sperm (forward and non-forward) ≥40% (A + B + C ≥40%)).② Total motile sperm number ≥9 million.That is, the percentage of semen volume × semen density × motility sperm ≥9×10\^6.
  • Tubal patency tests, including hysterosalpingography and diagnostic laparoscopy, which show that at least one fallopian tube is open.(If there is no history of pelvic operation or abortion, patency test results are effective within 3 years;If there is a history of fertility within 5 years and there is no pelvic operation, the tubal patency test is not required).
  • Agree to discontinue the use of other therapies during the study. 6) Participate in the study voluntarily and sign the informed consent.

You may not qualify if:

  • In the last 2 months, use of hormones or other drugs, including TCM prescriptions and Chinese patent medicines, may affect the results.
  • Pregnancy history within the last 6 weeks.
  • A history of miscarriage or birth in the last 6 weeks.
  • A history of breastfeeding in the last 6 months.
  • Do not agree to sign the informed consent for this study.
  • PCOS women who do not belong to the syndrome of spleen-kidney Yang deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Interventions

LetrozoleAcupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsComplementary TherapiesTherapeutics

Study Officials

  • naiping wang, Chief physician

    Dongguan Hospital of Traditional Chinese Medicine

    STUDY DIRECTOR

Central Study Contacts

kewei Quan, attending doctor

CONTACT

0086 13416820860279271961@qq.com

Qiuping Lin, no

CONTACT

0086 150141655372758063750@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

July 15, 2021

First Posted

August 3, 2021

Study Start

August 3, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

The results were published within 6 months after the completion of the test.

Shared Documents
CSR
Time Frame
The results were published within 6 months after the completion of the test.
More information