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NCT Number: NCT02775734

NAC in CC Resistant PCOS After LOD

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.

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Key information

Conditions

Clomiphene Citrate Resistant Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-Acetyl-Cysteine

Drug

N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling

Clomiphene Citrate

Drug

Clomiphene citrate + Laparoscopic ovarian drilling

Primary outcomes

  1. Biochemical pregnancy rate

    Time frame: 6 months

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 6 months

  2. Live-birth rate

    Time frame: 15 months

  3. Ovulation rate

    Time frame: 6 months

  4. follicles more than or equal 18 mm

    Time frame: 6 months

  5. Pre-ovulatory endometrial thickness

    Time frame: 6 months

  6. mid-luteal sub-endometrial doppler blood flow indices

    Time frame: 6 months

  7. Incidence of side effects

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: NAC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 18, 2016
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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