Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Uncontrolled Trial to Assess the Non-immunogenicity and Safety of Org 36286 in Patients Undergoing Repeated Controlled Ovarian Stimulation Cycles Using a Multiple Dose GnRH Antagonist Protocol
Brief Summary: The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.


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: Pregnancy status at 20 weeks of gestation (one pregnancy period); Take-home baby rate (one pregnancy period)
C: 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)
D: Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) (Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial)

Answer: C