Back to resultsNAC in CC Resistant PCOS After LOD (NAC)
Primary Purpose
Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
N-acetyl-cysteine
Clomiphene citrate
Sponsored by
About this trial
This is an interventional treatment trial for Clomiphene Citrate Resistant Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, N-acetyl-cysteine, Clomiphene citrate, Clomiphene citrate resistant, Laparoscopic ovarian drilling, therapy
Eligibility 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
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
N-acetyl-cysteine
NO N-acetyl-cysteine
Arm Description
N-acetyl-cysteine + Clomiphene citrate + LOD
Clomiphene citrate + LOD
Outcomes
Primary Outcome Measures
Biochemical pregnancy rate
Secondary Outcome Measures
Clinical pregnancy rate
Live-birth rate
Ovulation rate
follicles more than or equal 18 mm
Pre-ovulatory endometrial thickness
mid-luteal sub-endometrial doppler blood flow indices
Incidence of side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02775734
Brief Title
NAC in CC Resistant PCOS After LOD
Acronym
NAC
Official Title
N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome, N-acetyl-cysteine, Clomiphene citrate, Clomiphene citrate resistant, Laparoscopic ovarian drilling, therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetyl-cysteine
Arm Type
Active Comparator
Arm Description
N-acetyl-cysteine + Clomiphene citrate + LOD
Arm Title
NO N-acetyl-cysteine
Arm Type
Active Comparator
Arm Description
Clomiphene citrate + LOD
Intervention Type
Drug
Intervention Name(s)
N-acetyl-cysteine
Intervention Description
N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate
Intervention Description
Clomiphene citrate + Laparoscopic ovarian drilling
Primary Outcome Measure Information:
Title
Biochemical pregnancy rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
6 months
Title
Live-birth rate
Time Frame
15 months
Title
Ovulation rate
Time Frame
6 months
Title
follicles more than or equal 18 mm
Time Frame
6 months
Title
Pre-ovulatory endometrial thickness
Time Frame
6 months
Title
mid-luteal sub-endometrial doppler blood flow indices
Time Frame
6 months
Title
Incidence of side effects
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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NAC in CC Resistant PCOS After LOD
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