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
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
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
NCT ID
NCT02239107
First Posted
September 4, 2014
Last Updated
September 11, 2014
Sponsor
Assiut University
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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