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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Procedure: laparoscopic ovarian drilling; Drug: N-Acetyl cysteine

• Registration Number: NCT02239107
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-11
• Last Update Submitted: 2014-09-11
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic drilling group	laparoscopic ovarian drilling	laparoscopic drilling only will be done
N-Acetyl cysteine	laparoscopic ovarian drilling	Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month
N-Acetyl cysteine	N-Acetyl cysteine	Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month

Primary Outcome Measures

Name	Time	Method
ovulation rate	6 month	ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone

Secondary Outcome Measures

Name	Time	Method
pregnancy rate	2 years