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 38825 for Org 36286 (Corifollitropin Alfa)
Brief Summary: The objective of this trial 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. In addition, a primary efficacy variable, live birth rate, was evaluated.


Options:
A: Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate) (Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)); Number of Expectant Mothers Experiencing Adverse Events (AEs) (From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)); Number of Live Born Infants Experiencing AEs (Up to 12 weeks after birth); Number of Live Born Infants Experiencing SAEs (Up to 12 weeks after birth)
B: Percentage of Participants With Clinically Relevant Immunogenicity (Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle); Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Number of Participants With AEs (Up to approximately 26 months after first dose of corifollitropin alfa); Number of Participants With Serious AEs (SAEs) (Up to approximately 26 months after first dose of corifollitropin alfa); Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) (Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle)
C: 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))
D: Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) (Assessed at least 10 weeks after embryo transfer (up to 1 year)); Mean Number of Oocytes Retrieved (Up to 36 hours after administration of hCG (up to 1 year))

Answer: A