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.
The study will include 740 women with polycystic ovary syndrome undergoing IVF/ICSI cycle using flexible antagonist protocol. Randomization: Patients fulfilling the inclusion criteria will be randomized to two groups. Study Group: This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH. Control Group: This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will start GnRH antagonist COH directly without OCP pretreatment. Random allocation sequence generation: A computer generated list via MedCalc ® Software, version 13.2.2 will be used, assigning each participant number to either study groups. Allocation Concealment: Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminum foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail. IVF/ICSI cycle will be done using flexible anatgonist protocol in both groups. Primary outcome will be ongoing pregnancy rate. Secondary outcomes will be biochemical and clinical pregnancy rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
740
OCPs will be started from day 2 of the cycle preceding COH and continued for 21 days, then induction of ovulation using antagonist protocol will be started.
AinShams Maternity Hospital
Cairo, Egypt
RECRUITINGOngoing pregnancy rate
Number of pregnancies completing ≥20 weeks gestational age expressed per 100 embryo transfer cycles
Time frame: 20 gestational weeks
Chemical pregnancy rate
Number of biochemical pregnancies (evidenced by positive pregnancy test in serum or urine without ultrasound evidence of a gestational sac) expressed per 100 embryo transfer cycles
Time frame: 6 gestational weeks
Clinical pregnancy rate
Number of clinical pregnancies (evidenced by ultrasound visualization of a gestational sac and embryonic pole with heartbeat) expressed per 100 embryo transfer cycles
Time frame: 6 gestational weeks
Live birth rate
The number of deliveries (\> 28 weeks GA) that resulted in a live born neonate, expressed per 100 embryo transfers
Time frame: 38 gestational weeks
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