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The Clinical Trial of Acupuncture Pre-treatment on PCOS (PCOSAPct)

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ClinicalTrials.gov Identifier: NCT02491320
Recruitment Status : Unknown
Verified February 2016 by Hongxia Ma, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : July 8, 2015
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Hongxia Ma, The First Affiliated Hospital of Guangzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Other: Pre-treatment acupuncture Drug: Letrozole Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture Pre-treatment Combined With Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome
Study Start Date : August 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Pre-treatment acupuncture + letrozole
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
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.
Other Name: Pretreatment

Drug: Letrozole
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.
Other Name: Letrozole(Femara, Novartis Pharmaceuticals)

Active Comparator: Letrozole
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
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.
Other Name: Letrozole(Femara, Novartis Pharmaceuticals)




Primary Outcome Measures :
  1. Live birth rate [ Time Frame: Up to 18 months ]

Secondary Outcome Measures :
  1. Ovulation rate [ Time Frame: Up to 8 months ]
  2. Ongoing pregnancy rate [ Time Frame: Up to 11 months ]
  3. Multiple pregnancy rates [ Time Frame: Up to 18 months ]
  4. Miscarriage rate [ Time Frame: Up to 11 months ]
    Loss of an intrauterine pregnancy before 20 completed weeks of gestation

  5. Pregnancy complications rate [ Time Frame: Up to 18 months ]
  6. Hormonal profile [ Time Frame: Up to 8 months ]
    FSH, LH, T, SHBG and DHEAS

  7. Metabolic profile [ Time Frame: Up to 8 months ]
    Glucose and insulin concentrations, C-peptide, HbA1c, cholesterol, triglycerides, HDL-C and LDL-C

  8. HOMA-IR [ Time Frame: Up to 8 months ]
  9. Body composition(a composite) [ Time Frame: Up to 8 months ]
    Weight, BMI, waist-to-hip circumference, FG and acne lesion counts

  10. Questionnaires(a composite) [ Time Frame: Up to 8 months ]
    SF-36, ChiQOL, sleeping questionnaires, PCOS-QOL, Zung SAS, Zung SDS questionnaires and the quantization table of TCM syndromes about PCOS.

  11. Side effect profile [ Time Frame: Up to 18 months ]
  12. AUCglu [ Time Frame: Up to 8 months ]
  13. AUCins [ Time Frame: Up to 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged between 20 and 40 years.
  2. Confirmed diagnosis of PCOS according to 2003 modified Rotterdam criteria
  3. 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.
  4. 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.

Exclusion Criteria:

1) Exclusion of other endocrine disorders:

  • 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.

          3) Acupuncture the last 2 months. 4) Pregnancy within the past 6 weeks. 5) Within 6 weeks post-abortion or postpartum. 6) Breastfeeding within the last 6 months. 7) Not willing to give written consent to the study. 8) Additional exclusion criteria

          1. Patients with a suspected adrenal or ovarian tumor secreting androgens. 2. Couples with previous sterilization procedures (vasectomy, tubal ligation) which have been reversed. The prior procedure may affect study outcomes, and patients with both a reversed sterilization procedure and PCOS are rare enough that exclusion should not adversely affect recruitment.

          3. 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.

          4. 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.

          5. 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.

          7. 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.

          8. Patients with significant anemia (Hemoglobin < 10 g/dL). 9. Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.

          10. Patients with known heart disease that is likely to be exacerbated by pregnancy.

          11. 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.

          12. Patients with a current history of alcohol abuse. Alcohol abuse is defined as >14 drinks/week or binge drinking.

          13. Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.

          14. Patients who anticipate taking longer than a one month break during the protocol should not be enrolled.

          15. Patients taking other medications known to affect reproductive function or metabolism. These medications include oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs, Chinese herbal formula, anti-diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers. The washout period on all these medications will be two months.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491320


Contacts
Contact: Hongxia Ma, PhD 18928868335 ext 02083177207 doctorhongxia@126.com
Contact: Juan Li, PhD 13802780603 ext 02083177207 lijua@163.com

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Wanting Wu, Master    15818153730      
Contact: Meifang Li, Master    13544426679      
Principal Investigator: Hongxia Ma, PhD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
The University of Hong Kong
Investigators
Study Chair: Hongxia Ma, PhD The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Juan Li, PhD The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Maohua Lai, PhD The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Hua Liu, Master The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Xinghua Song, Master The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Wanting Wu, Master The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Ernest HY NG, PhD The University of Hong Kong

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hongxia Ma, Professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02491320     History of Changes
Other Study ID Numbers: PCOSAPct
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by Hongxia Ma, The First Affiliated Hospital of Guangzhou Medical University:
polycystic ovary syndrome
acupuncture
pre-treatment
Letrozole
Live Birth

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Letrozole
Progestins
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormones