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

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ClinicalTrials.gov Identifier: NCT02239107
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
esraa yousef badran, 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: N-Acetyl cysteine Procedure: laparoscopic ovarian drilling Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: N-acetyl Cysteine as an Adjuvant Therapy to Laparoscopic Ovarian Drilling in Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014


Arm Intervention/treatment
Experimental: 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
Drug: N-Acetyl cysteine
Other Names:
  • Acetyl cysteine
  • NAC

Procedure: laparoscopic ovarian drilling
Active Comparator: laparoscopic drilling group
laparoscopic drilling only will be done
Procedure: laparoscopic ovarian drilling



Primary Outcome Measures :
  1. ovulation rate [ Time Frame: 6 month ]
    ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone


Secondary Outcome Measures :
  1. pregnancy rate [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: esraa yousef badran, Esraa yousef Badran, Assiut University
ClinicalTrials.gov Identifier: NCT02239107     History of Changes
Other Study ID Numbers: n-acetyl cysteine PCOS
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

Keywords provided by esraa yousef badran, Assiut University:
polycystic ovary syndrome
laparoscopic drilling
clomiphene citrate
n acetyl cysteine
insulin resistance

Additional relevant MeSH terms:
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Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Acetylcysteine
N-monoacetylcystine
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents