The primary purpose of this study is to collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this incidence with that of a group of women who used a long protocol with a gonadotropin releasing hormone agonist as historical controls.

Inclusion Criteria:

• Puregon® (recFSH)/Orgalutran® group:

  • Women with a pregnancy of >= 16 weeks after Puregon® /Orgalutran® treatment for IVF or ICSI and ET of fresh embryos. Treatment is defined as having had at least one injection of Orgalutran®.
  • Women between 18 and 39 years of age (inclusive) at the day of hCG.
  • Women who are able and willing to sign informed consent.

Controls

• Infants (gestational age >=16 weeks) of women pregnant after COH using a GnRH agonist in a long protocol for IVF or ICSI and ET of fresh embryos.
• Infants of women between 18 and 39 years of age (inclusive) at the day of hCG.
• The most recent 1000 infants delivered prior to January 1, 2001.

Exclusion Criteria:

• None

Single site study; A total of approximately 2000 infants born after IVF or ICSI: app. 1000 infants born after ongoing pregnancies resulting from COH including Puregon/Orgalutran treatment followed by IVF or ICSI and app. 1000 infants born after treatment with a long agonist protocol followed by IVF or ICSI as controls.