Yarali 1999.
Methods | Prospective, randomised trial Duration, timing, and location of the trial: not stated Sample size calculation: not stated 51 women randomised 3 cycles/woman Ratio between uFSH and rFSH was approximately 2:1. Per protocol and intention‐to‐treat analyses were performed |
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Participants | Clomiphene citrate‐resistant WHO Group II chronic anovulatory women (see Notes) Mean age (± SD) of the women in years was 27.8 (4.8) for the uFSH group and 30.0 (5.8) for the rFSH group Body mass index (± SD) was 27.1 (5.5) and 27.1 (3.7), respectively Duration of infertility in years (± SD) was 7.0 (5.6) and 9.0 (4.2), respectively Number of women with primary infertility was 57.1% and 64.5%, respectively LH:FSH ratio (± SD) was 2.4 (1.3) and 3.4 (5.5), respectively Infertility work‐up consisted of endocrinology (FSH, prolactin, TSH, testosterone), tubal tests by hysterosalpingography or laparoscopy, or hysteroscopy, and semen analysis |
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Interventions | uFSH versus rFSH as second‐line treatment Treatment was started 3 to 5 days after a spontaneous, or progesterone‐induced menstrual bleed Starting dose was 75 IU daily, and was maintained for up to 14 days unless follicular maturity was reached. After this, the dose was maintained, or increased by 37.5 IU according to individual response. The maximum allowed daily dose was 225 IU hCG (10,000 IU, Profasi HP) was given when a single follicle of ≥ 17 mm was detected. hCG was not given in cases of > 4 follicles of ≥ 15 mm |
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Outcomes | Ovulation rate Clinical pregnancy rate Number of follicles Endometrial thickness at the time of hCG administration Duration of luteal phase Incidence of OHSS Total FSH dose and duration of stimulation FSH level on day of hCG administration Miscarriages Multiple pregnancies Number of cancellations |
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Notes | Clomiphene‐resistant: consistent failure to ovulate with incremental doses of clomiphene citrate up to 150 mg/day in 3 previous cycles, or failure to conceive with the ovulatory dose during 6 previous cycles Ovulation: mid‐luteal serum progesterone concentration of > 5 ng/mL Clinical pregnancy: transvaginal ultrasound showing at least 1 gestational sac OHSS: Not defined |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was based on a participant number from a randomisation list corresponding with patient drug codes |
Allocation concealment (selection bias) | High risk | Participant number from a randomisation list |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding was performed |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding was performed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 11 treatment cycles were cancelled because of > 4 follicles of > 15 mm, or a lack of response. ITT and per protocol analysis |
Selective reporting (reporting bias) | Low risk | Intended outcomes reported. |
Other bias | Unclear risk | Insufficient information was available to evaluate this risk |
Funding | Unclear risk | rFSH was provided by Ares‐Serono |