Please select the outcome measures that correspond to the clinical trial below.
Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of Org 36286 (Corifollitropin Alfa)
Brief Summary: The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring.


Options:
A: Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)); Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)); Number of Mothers With Adverse Events (AEs) During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)); Number of Mothers With Serious AEs (SAEs) During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)); Number of Infants With AEs During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study); Number of Infants With SAEs During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study)
B: Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Adverse Events (AEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Infants Experiencing AEs (Up to 12 weeks after birth); Number of Infants Experiencing SAEs (Up to 12 weeks after birth)
C: Pregnancy status at 20 weeks of gestation; Take-home baby rate (one pregnancy period)
D: Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) (Up to one day following delivery (up to 1 year)); Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) (Up to one day following delivery (up to 1 year)); Number of Infants Born in Current Follow Up Trial Experiencing AEs (Up to 12 weeks following delivery (up to 1 year)); Number of Infants in Current Follow Up Trial Experiencing SAEs (Up to 12 weeks following delivery (up to 1 year)); Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. (At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)); Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. (At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year))

Answer: B