OCP Pretreatment in PCOS Patients Undergoing ICSI Using Antagonist Protocol (NCT03881904) | Clinical Trial Compass
UnknownPhase 1/2
OCP Pretreatment in PCOS Patients Undergoing ICSI Using Antagonist Protocol
Egypt740 participantsStarted 2017-06-01
Plain-language summary
373 women with PCOS undergoing a trial of IVF/ICSI will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.
Another 373 women with PCOS undergoing a trial of IVF/ICSI will start GnRH antagonist COH directly without OCP pretreatment.
Both groups will be followed up for effect on ongoing pregnancy rate.
Who can participate
Age range18 Years – 39 Years
SexFEMALE
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Inclusion criteria
✓. Age 18-39 years of age.
✓. BMI 18-29 Kg/m2
✓. Polycystic ovary syndrome, diagnosed - according to the revised 2003 consensus on diagnostic criteria of polycystic ovary syndrome by the Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group - by the presence of two of the following three diagnostic features:
✓. Oligo- or anovulation \[defined as fewer than eight episodes of menstrual bleeding per year or menses that occur at intervals greater than 35 days\].
✓. Clinical hyperandrogenism \[defined by the presence of hirsutism (assessed by a modified Ferriman-Gallwey score ≥ 8), acne or androgenic alopecia\] and/or biochemical signs of hyperandrogenism \[defined by elevated free androgen index\]
✓. Polycystic ovaries \[defined as presence of 12 or more follicles in each ovary measuring 2 - 9 mm in diameter, and/or increased ovarian volume \> 10 mL) in the early follicular phase (cycle days 3 - 5) in regularly menstruating women. Oligo-/amenorrhoeic women should be scanned either at random or between days 3 and 5 after a progestin-induced withdrawal bleeding. This definition does not apply to women taking oral contraceptive pills, since their use modifies ovarian morphology in normal women and putatively in women with PCO.
Exclusion criteria
✕. Normal transvaginal ultrasonography apart from polycystic ovaries (see before).