Chen 2016.
Study characteristics | ||
Methods | Randomised controlled trial Duration and location of the trial: quote: "All patients were admitted in our hospital between January 2013 and January 2015, who were not pregnant without contraception for over one year.“ |
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Participants |
Inclusion criteria: quote: "all the cases were PCOS infertility patients in line with the PCOS diagnostic criteria of the 2003 Rotterdam Conference, i.e. at least two of the following three were met: 1) ovulation abnormality (sporadic ovulation or no ovulation) occurred after continuous monitoring for two or more natural cycles; 2) the results of B ultrasound showed polycystic ovary; 3) patients had hyperandrogenism or showed clinical manifestations of androgen excess. Through salpingography or hydrotubation under transvaginal B ultrasound and other examinations, all cases were confirmed to have tubal patency on at least one side. The semen of male was normal." Exclusion criteria: quote:"Those with androgen excess caused by other diseases such as adrenal hyperplasia Cushing’s syndrome and androgen‐secreting tumours were excluded. Exclusion criteria: 1) Infertility patients caused by non‐PCOS ovulatory disorder or other factors; 2) patients with history of ovarian surgery or complication with endometriosis or pelvic adhesion; 3) patients complicated with liver, kidney or thyroid dysfunction; 4) patients who did not receive treatment after enrolment according to the established regimen or gave up in the midst of treatment." Number of women randomised: 156 patients, 52 in each group Number of women analysed: 156 patients, 52 in each group Number of withdrawals/exclusions/loss to follow‐up and reasons: none reported Number of centres: single‐centre trial Age (y): letrozole group 26.4 ± 4.2; CC group 27.1 ± 4.7; letrozole + hMG group 27.7 ± 5.2 years BMI (kg/m²): letrozole group 22.4 ± 4.5; CC group 23.4 ± 1.5; letrozole + hMG group 22.6 ± 2.6 years Duration of infertility (y): letrozole group 3.4 ± 1.1; CC group 3.2 ± 0.7; letrozole + hMG group 3.3 ± 1.3 years Country: China |
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Interventions |
Group A (letrozole): the participants orally took 2.5 mg/d‐1 to 5.0 mg/d‐1 letrozole (trade name: Fu Rui, Jiangsu Hengrui Medicine Co, Ltd.) on the 3rd ‐ 5th days of menstrual cycle for 5 consecutive days. Group B (CC group): the participants were orally administered with 50 mg/d‐1 to 100 mg/d‐1 CC (trade name: Fertilan, Codal Synto Pharmaceutical Co, Ltd.) on the 3rd ‐ 5th days of menstrual cycle for 5 consecutive days. Group C(letrozole + hMG group): the participants orally took 2.5 mg/d‐1 to 5.0 mg/d‐1 letrozole on the 3rd ‐ 5th days of menstrual cycle for 5 consecutive days. Starting from the day of oral administration of CC, 75 IU hMG (trade name: Lebaode, Livzon Group Livzon Pharmaceutical Co. Ltd.) was intramuscularly injected every other day for 5 consecutive days. |
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Outcomes |
Primary outcomes: clinical pregnancy, defined as a foetal heart beat visible via transvaginal ultrasound on 30th day after ovulation Secondary outcomes: OHSS, miscarriage (abortion), multiple pregnancy |
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Notes |
Ethical approval: this trial has been approved by the ethics committee of our hospital. Informed consent: written consent has been obtained from all patients. Source of funding: quote: “None” Power calculation: no power calculation was 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 randomly divided into an LE group, a CC group and an LE + hMG group” |
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 | Low risk | All participants randomised were also analysed. |
Selective reporting (reporting bias) | Low risk | No trial protocol was found, but all outcomes reported were also analysed. |
Other bias | Low risk | None |