NAC in CC Resistant PCOS After LOD

Clomiphene Citrate Resistant Polycystic Ovary Syndrome Clinical Trial

— NAC  

Official title:

N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775734
• Other study ID #: AS1275
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 16, 2016
• Last updated: April 28, 2017
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Clomiphene Citrate Resistant Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• N-acetyl-cysteine
N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling
• Clomiphene citrate
Clomiphene citrate + Laparoscopic ovarian drilling

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical pregnancy rate		6 months
Secondary	Clinical pregnancy rate		6 months
Secondary	Live-birth rate		15 months
Secondary	Ovulation rate		6 months
Secondary	follicles more than or equal 18 mm		6 months
Secondary	Pre-ovulatory endometrial thickness		6 months
Secondary	mid-luteal sub-endometrial doppler blood flow indices		6 months
Secondary	Incidence of side effects		6 months