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
Exclusion criteria:
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. |