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.
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.
Study Type
OBSERVATIONAL
Enrollment
113
Single injection of 100 μg corifollitropin alfa administered under protocol P05690
Daily recFSH administered under protocol P05690
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)
The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.
Time frame: 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)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: 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)
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time frame: 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
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Up to 12 weeks after birth
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hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690
Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690
Number of Infants Experiencing SAEs
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time frame: Up to 12 weeks after birth