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NAC in CC Resistant PCOS After LOD (NAC)

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ClinicalTrials.gov Identifier: NCT02775734
Recruitment Status : Completed
First Posted : May 18, 2016
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

Brief Summary:
This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation, mid- luteal sub-endometrial blood flow indices, and incidence of side effects.

Condition or disease Intervention/treatment Phase
Clomiphene Citrate Resistant Polycystic Ovary Syndrome Drug: N-acetyl-cysteine Drug: Clomiphene citrate Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial
Study Start Date : May 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017


Arm Intervention/treatment
Active Comparator: N-acetyl-cysteine
N-acetyl-cysteine + Clomiphene citrate + LOD
Drug: N-acetyl-cysteine
N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling

Drug: Clomiphene citrate
Clomiphene citrate + Laparoscopic ovarian drilling

Active Comparator: NO N-acetyl-cysteine
Clomiphene citrate + LOD
Drug: Clomiphene citrate
Clomiphene citrate + Laparoscopic ovarian drilling




Primary Outcome Measures :
  1. Biochemical pregnancy rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 6 months ]
  2. Live-birth rate [ Time Frame: 15 months ]
  3. Ovulation rate [ Time Frame: 6 months ]
  4. follicles more than or equal 18 mm [ Time Frame: 6 months ]
  5. Pre-ovulatory endometrial thickness [ Time Frame: 6 months ]
  6. mid-luteal sub-endometrial doppler blood flow indices [ Time Frame: 6 months ]
  7. Incidence of side effects [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 25 and 30 Kg/m 2.
  • CC-resistant Polycystic ovary syndrome

Exclusion Criteria:

  • • Patients with BMI under 25 or over 30 Kg/m 2.

    • Hyper or hypothyroidism, or hyperprolactinemia.
    • Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.
    • Intention to start a diet or a specific program of physical activity.
    • Organic pelvic diseases.
    • Tubal or male factor infertility.
    • Interval of earlier treatment with any of the fertility drugs of less than 6 months.
    • Contraindication to either:

      • Clomiphene citrate: liver disease, undiagnosed abnormal uterine bleeding, uterine fibroids, endometrial cancer, ovarian enlargement or hyper stimulation
      • HCG injection: ovarian enlargement or hyper stimulation

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): NCT02775734


Locations
Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

Responsible Party: Mohamed S Sweed, MD, Dr, Ain Shams University
ClinicalTrials.gov Identifier: NCT02775734     History of Changes
Other Study ID Numbers: AS1275
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mohamed S Sweed, MD, Ain Shams University:
Polycystic Ovary Syndrome
N-acetyl-cysteine
Clomiphene citrate
Clomiphene citrate resistant
Laparoscopic ovarian drilling
therapy

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
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Acetylcysteine
N-monoacetylcystine
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents