The Clinical Trial of Acupuncture Pre-treatment on PCOS

NCT02491320 | Completed Phase 3 DMC

• 1 other identifier: PCOSAPct
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study protocol for a multicenter, randomized, and controlled trial. In this protocol, we present a randomized controlled trial comparing acupuncture pretreatment followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS women is considered to be one of the major pathophysiological changes of PCOS, leading to anovulatiory infertility. A study has shown that electro-acupuncture could significantly improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS women followed by ovulation induction has not been investigated before. A total of 384 patients enrolled in this study will be randomized into one of two groups. The treatment group: a 16 week acupuncture pretreatment followed by 4 cycles of letrozole and the control group: 4 cycles of letrozole alone. The primary outcome is the live birth rate. We postulate that acupuncture pretreatment followed by letrozole results in a higher live birth rate when compared with letrozole alone.

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndrome; acupuncture; pre-treatment; Letrozole; Live Birth

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Live birth rate

  Up to 18 months

Secondary Outcomes (13)

• Ovulation rate

  Up to 8 months

• Ongoing pregnancy rate

  Up to 11 months

• Multiple pregnancy rates

  Up to 18 months

• Miscarriage rate

  Up to 11 months

• Pregnancy complications rate

  Up to 18 months

Study Arms (2)

Pre-treatment acupuncture + letrozole

EXPERIMENTAL

A 16 week acupuncture pretreatment followed by letrozole(LE). Acupuncture treatment will start on day 3-5 after a spontaneous period or after a withdrawal bleeding following progestin. All subjects will be requested to use contraception during the 16 week acupuncture pretreatment. They will receive acupuncture treatment three times a week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 16 weeks. After 16 weeks of acupuncture treatment, LE will start on day 2-3 after a spontaneous period or after a withdrawal bleeding after progestin administration. The subjects will be instructed to have intercourse on a regular basis during the cycles.

Other: Pre-treatment acupuncture; Drug: Letrozole

Letrozole

ACTIVE COMPARATOR

LE alone. LE will be started on day 3-5 after a spontaneous period or a withdrawal bleeding following progestin. The subjects will be instructed to have intercourse on a regular basis during the cycles.

Drug: Letrozole

Interventions

Pre-treatment acupuncture OTHER

Acupuncture treatment will start on day 3-5 after a spontaneous period or after a withdrawal bleeding following progestin. They will receive acupuncture treatment three times a week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 16 weeks.

Also known as: Pretreatment

Pre-treatment acupuncture + letrozole

Letrozole DRUG

Starting from 2.5mg daily from day 3-5 for 5 days after a spontaneous period or after a withdrawal bleeding following progestin, one time per day.Participants are treated for up to 4 cycles.

Also known as: Letrozole(Femara, Novartis Pharmaceuticals)

Letrozole; Pre-treatment acupuncture + letrozole

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 20 and 40 years.
• Confirmed diagnosis of PCOS according to 2003 modified Rotterdam criteria
• According to World Health Organization standards (2010), semen analysis of the husband must meet ① or ②. ①sperm concentration ≥15\*106/ml and total motility ≥40% . ② Total motile sperm count ≥9 million, i.e. semen volume\*sperm density\*percentage of motile sperm ≥9 million.
• At least one patent tube shown by hysterosalpingogram or diagnostic laparoscopy. The results will be valid for 3 years if the patients do not have a history of abortion or pelvic operation.

You may not qualify if:

• Patients with hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values). The goal of eliminating patients with documented hyperprolactinemia is to decrease the heterogeneity of the PCOS population. These patients may be candidates for ovulation induction with alternate regimens (dopamine agonists). A normal level within the last year or on treatment is adequate for entry.
• Patients with FSH levels \> 15 mIU/mL. A normal level within the last year is adequate for entry.
• Patients with uncorrected thyroid disease (defined as TSH \< 0.2 mIU/mL or \>5.5 mIU/mL). A normal level within the last year is adequate for entry.
• Patientsdiagnosed with Type I or Type II diabetes who are poorly controlled (defined as a Hb A1c level \> 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; Patients currently receiving metformin XR (extended release) for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
• ⑤Patients with suspected Cushing's syndrome. 2) Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 2 months.
• \. Subjects who have undergone a bariatric surgery procedure in the recent past (\<12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon.
• \. Patients with untreated poorly controlled hypertension defined as a systolic blood pressure 160 mm Hg or a diastolic 100 mm Hg obtained on two measures obtained at least 60 minutes apart.
• \. Patients with known congenital adrenal hyperplasia. 6. Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins.
• \. Patients with liver disease defined as AST or ALT \> 2 times normal or totalbilirubin \>2.5 mg/dL. Patients with renal disease defined as BUN \> 30 mg/dL or serum creatinine\> 1.4 mg/dL.
• \. Patients with significant anemia (Hemoglobin \< 10 g/dL). 9. Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
• \. Patients with known heart disease that is likely to be exacerbated by pregnancy.
• \. Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal Pap smear or TCT result will be required for women 21 and over.
• \. Patients with a current history of alcohol abuse. Alcohol abuse is defined as \>14 drinks/week or binge drinking.
• \. Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
• \. Patients who anticipate taking longer than a one month break during the protocol should not be enrolled.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• The University of Hong Kong: collaborator
• Karolinska Institutet: collaborator
• Xuzhou Maternity and Child Health Care Hospital: collaborator
• Hexian Memorial Affiliated Hospital of Southern Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (29)

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MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Treatment Expectations; Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Treatment Outcome; Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hongxia Ma, PhD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

• Juan Li, PhD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Elisabet Stener-Victorin, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Ernest HY NG, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

CN (1)