Sharief 2015.
| Methods | Randomised controlled clinical trial Duration and location of the trial: quote: "The prospective clinical trial was conducted at Basrah Maternity and Child Hospital, Basrah, Iraq, between January 2012 and April 2013, and comprised women with PCOS and primary infertility.“ |
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| Participants |
Inclusion criteria: quote: "Women with PCOS and primary infertility. The subjects were selected from among those who were attending the infertility centre with primary infertility, which was defined as inability of a couple to obtain pregnancy after 1‐2 years of unprotected intercourse. All subjects were diagnosed as having anovulation due to PCOS. PCOS was diagnosed when the ultrasonographic (USG) findings of the ovaries were >10 follicles 2‐8 mm in diameter scattered either around or through an echodense thickened central stroma. In addition, there had to be one or more of the following: oligomenorrhoea, positive progesterone, withdrawal bleeding, hirsutism/acne, obesity, and Luteinizing hormone/Follicle‐stimulating hormone (LH/FSH) ratio >2 or raised circulating androgen, normal thyroid stimulating hormone (TSH). Those included were aged between 18 and 36 years, period of infertility was more than 2 years, serum prolactin level was normal, serum FSH <12u/L, normal thyroid function, and hirsutism, which was diagnosed when the Ferriman and Gallwey score was >8.9 Besides, the male partners had to have a normal seminal analysis by World Health Organisation (WHO) criterion." Exclusion criteria: all women having had patent tubes by either hysterosalpingogram or laparoscopy, history of pelvic surgery with tubal blockage were excluded from the study. Number of women randomised: not stated how many participants were randomised Number of women analysed: 75 women were analysed, 40 in group A, 35 in group B Number of withdrawals/exclusions/loss to follow‐up and reasons: not stated Number of centres: single centre Age (y): group A 25.3 ± 2.1 years, group B 26.1 ± 1.3 years BMI (kg/m²): group A 27.8 ± 1.7, group B 28.1 ± 1.9 Duration of infertility (y): group A 2.3 ± 0.4, group B 2.4 ± 0.6 Country: Iraq |
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| Interventions |
Group A: clomiphene citrate for 6 months with a dose between 100 ‐ 200 mg for 5 days beginning on day 3 of the menstrual cycle Group B: letrozole 2.5 ‐ 5 mg daily for 5 days starting from the 3rd day of a spontaneous or progesterone‐induced menstrual bleeding |
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| Outcomes | Pregnancy rate, multiple pregnancies, follicular development,N of follicles, serum E2 on day of HCG, endometrial thickness, ovulation rate | |
| Notes |
Ethical approval: approval was obtained from the ethical committee of the College of Medicine, University of Basrah, Iraq. Informed consent: not reported if informed consent was obtained Source of funding: not reported Power calculation: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were randomised into two groups." |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported how many women were randomised in first instance |
| Selective reporting (reporting bias) | Unclear risk | No study protocol was found |
| Other bias | Low risk | None |