Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
Condition: Pregnancy; Neonates
Study type: Observational

Summary: 
      The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org
      36286) treatment for the induction of monofollicular growth in women who underwent ovulation
      induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their
      offspring.
    

Detailed description: 
      Base study P05693 (NCT00697255) was planned to include two separate stages (Ia+Ib and II).

      Stage Ia was open-label and uncontrolled in a small cohort of women (n=5) to explore whether
      the intended dosing regimen of corifollitropin alfa followed by daily low dose recombinant
      Follicle Stimulating Hormone (recFSH) would provide an appropriate response in eligible
      participants meeting all inclusion and none of the exclusion criteria.

      Stage Ib was open-label and uncontrolled in a small cohort of women (n=3) to explore whether
      the intended dosing regimen of corifollitropin alfa followed by daily low dose Human Chorion
      Gonadotropin (hCG) would provide an appropriate response in eligible participants meeting all
      inclusion and none of the exclusion criteria.

      Stage II was planned to be open-label and randomized (n=40) to evaluate whether the intended
      dosing regimen of corifollitropin alfa followed by low dose recFSH (n=20) or hCG (n=20) would
      provide an appropriate response in eligible participants meeting all inclusion and none of
      the exclusion criteria.

      P05713 is a follow-up (FU) study to prospectively monitor pregnancy, delivery, and neonatal
      outcome of women who became ongoing pregnant during base study P05693 (NCT00697255). For this
      trial, no study specific assessments will be required and no treatment will be administered,
      but information as obtained in standard practice will be used. Enrollment will begin when the
      first ongoing pregnancy resulting from the base study has been established (ultrasound ≥ 10
      weeks after bolus injection of hCG).
    

Intervention name(s): corifollitropin alfa; recombinant Follicle Stimulating Hormone (recFSH); human Chorion Gonadotropin (hCG); hCG Bolus injection
Intervention type(s): Drug; Biological; Biological; Biological
Intervention description(s): SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.; Daily injections of SC recFSH (50 IU/75 IU) were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.; Daily injections of SC hCG injection were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.; Bolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study.
Other intervention name(s): Org 36286; MK-8962; SCH 900962
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with an ongoing pregnancy at least 10 weeks after bolus injection of hCG in base
        study P05693 (NCT00697255).
      
Keywords: Neonatal outcome; Congenital malformations; Ovulation Induction; Follow-up