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N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
N-Acetyl cysteine
laparoscopic ovarian drilling
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, laparoscopic drilling, clomiphene citrate, n acetyl cysteine, insulin resistance

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • PCOS patients according to Rotterdam criteria who failed to respond to 6 month ovulation induction therapy with clomiphene citrate,
  • normal semen analysis of partner
  • normal tubo-peritoneal anatomy as assessed by laparoscopy

Exclusion Criteria:

  • patients who have other causes of infertility
  • patients receiving gonadotrophin ovulation induction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    N-Acetyl cysteine

    laparoscopic drilling group

    Arm Description

    Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month

    laparoscopic drilling only will be done

    Outcomes

    Primary Outcome Measures

    ovulation rate
    ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone

    Secondary Outcome Measures

    pregnancy rate

    Full Information

    First Posted
    September 4, 2014
    Last Updated
    September 11, 2014
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02239107
    Brief Title
    N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome
    Official Title
    N-acetyl Cysteine as an Adjuvant Therapy to Laparoscopic Ovarian Drilling in Clomiphene Citrate Resistant Polycystic Ovary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction. Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy, some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and pregnancy rate.
    Detailed Description
    Resistance to ovulation induction therapy with clomiphene citrate (CC) is a significant problem affecting as many as 25% of patients. Laparoscopic ovarian drilling is an accepted second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the CC resistant patients. Adjuvants to laparoscopic drilling have been explored by researchers some studies have shown evidence of improved outcome with the use of N-Acetyl cystiene (NAC), a long used mucolytic drug which has been used for various other indications including detoxification and cancer chemoprotection. Several studies have addressed the possibility of using NAC as adjuvant therapy to Clomiphene citrate for induction of ovulation in resistant patients with some showing encouraging results. The use of NAC as adjuvant to laparoscopic ovarian drilling was addressed in a single pilot study showing good results with improved ovulation and pregnancy rates compared to the non users.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    polycystic ovary syndrome, laparoscopic drilling, clomiphene citrate, n acetyl cysteine, insulin resistance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    N-Acetyl cysteine
    Arm Type
    Experimental
    Arm Description
    Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month
    Arm Title
    laparoscopic drilling group
    Arm Type
    Active Comparator
    Arm Description
    laparoscopic drilling only will be done
    Intervention Type
    Drug
    Intervention Name(s)
    N-Acetyl cysteine
    Other Intervention Name(s)
    Acetyl cysteine, NAC
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic ovarian drilling
    Primary Outcome Measure Information:
    Title
    ovulation rate
    Description
    ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    pregnancy rate
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: PCOS patients according to Rotterdam criteria who failed to respond to 6 month ovulation induction therapy with clomiphene citrate, normal semen analysis of partner normal tubo-peritoneal anatomy as assessed by laparoscopy Exclusion Criteria: patients who have other causes of infertility patients receiving gonadotrophin ovulation induction

    12. IPD Sharing Statement

    Learn more about this trial

    N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome

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