Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
Condition: Pregnancy; Neonates
Study type: Observational

Summary: 
      The objective of this trial was to evaluate whether Corifollitropin Alfa 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) was safe for
      pregnant participants and their offspring. The primary endpoint was the take-home baby rate
      calculated as the number of participants with an ongoing pregnancy in Base Trial P05787
      (NCT00696800) with at least one live born infant relative to the number of participants in
      the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer
      (ET).
    

Detailed description: 
      This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal
      outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant
      during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are
      required, but information as obtained in standard practice will be used.
    

Intervention name(s): Corifollitropin Alfa 150 μg; 200 IU RecFSH/Follitropin beta (Days 1 to 7); Placebo for Corifollitropin Alfa; Placebo for RecFSH/Follitropin beta; 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Ganirelix; hCG; Progesterone
Intervention type(s): Drug; Biological; Drug; Drug; Biological; Drug; Biological; Biological
Intervention description(s): In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.; In the Base Trial P05787, daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.; In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection from a pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa was administered in the abdominal wall.; In the Base Trial P05787, daily SC injections of an identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen, were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.; In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.; In the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG.; In the Base Trial P05787, when 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP; In the Base Trial P05787, on the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
Other intervention name(s): follitropin beta; Puregon®; Follistim®
Intervention MeSH terms: Progesterone; Follicle Stimulating Hormone; Ganirelix
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with an ongoing pregnancy at least 10 weeks after ET in Base Trial P05787
        (NCT00696800) were enrolled in this trial.
      
Keywords: Neonatal outcome; Congenital malformations; In-Vitro fertilization; Controlled ovarian stimulation; Follow-up