NAC in CC Resistant PCOS After LOD

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02775734

Collaborator

(none)

144

Enrollment

Location

Arms

Duration (Months)

14.4

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Biochemical pregnancy rate [6 months]

Secondary Outcome Measures

Clinical pregnancy rate [6 months]
Live-birth rate [15 months]
Ovulation rate [6 months]
follicles more than or equal 18 mm [6 months]
Pre-ovulatory endometrial thickness [6 months]
mid-luteal sub-endometrial doppler blood flow indices [6 months]
Incidence of side effects [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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