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. 2022 Sep 27;2022(9):CD010287. doi: 10.1002/14651858.CD010287.pub4

Kamel 2019.

Methods Randomised controlled trial
Duration and location of the trial: quote: "The current study was a randomized open‐labeled controlled study conducted in Assiut Women Health Hospital between April 2017 and October 2018."
Participants Inclusion criteria: all primary and secondary infertile women less than 39 years due to anovulation due to PCOD according to Rotterdam diagnostic criteria
  • Primary or secondary infertility.

  • Absence of galactorrhoea

  • Normal serum prolactin

  • Normal Hysterosalpinography

  • Husband has normal semen analysis


Exclusion criteria:
  • Male factor infertility, tubal factor infertility

  • Endocrinopathy as (hypothyroidism, hyperprolactinemia)

  • BMI > 35 kg/m2

  • Patients with previous ovarian surgery including LOD


Number of centres: single‐centre trial
Number of women randomised: 120
Number of women analysed: 110
Number of withdrawals/exclusions/loss to follow‐up and reasons: 5 in each group respectively, lost to follow‐up
Age (y): group A CC + NAC: 27.89 ± 5.92; Group B Let: 27.84 ± 5.17
BMI (kg/m²): group A CC + NAC: 28.67 ± 3.0; Group B Let: 27.28 ± 3.43
Duration of infertility (y): Group A CC + NAC: 3.08 ± 2.17; Group B Let: 2.96 ± 1.75
Country: Egypt
Interventions Group A: quote: "CC 100 mg +NAC 600 mg started from third day of cycle for 5 days."
Group B: quote: "Lertozole 5 mg alone started from third day of cycle for 5 days."
Outcomes Primary outcome: ovulation rate in both groups
Secondary outcomes: mid‐cyclic endometrial thickness, OHSS, clinical pregnancy and miscarriage rates
Notes Ethical approval: yes, quote: "The Institutional Ethical Review board approved the study."
Informed consent: yes, quote: "All patients signed informed written consent before participation in the study."
Source of funding: not stated
Conflicts of interest: not stated
Power calculation: not stated
Trial was moved to awaiting classification as there are concerns about the validity of the trial data.