Safety of Ovaleap® (Follitropin alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies. A Multi-National, Comparative, Prospective, Non-Interventional, Observational Cohort Study (SOFIA)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  OVALEAP

  GONAL-F
• Medical condition to be studied:
  Infertility

Population studied

• Short description of the study population:
  The study population will comprise infertile women, who have not previously received treatment with any FSH (ie, r-hFSH, u-hFSH) and/or hMG, who are undergoing ART and are administered Ovaleap or Gonal-f for ovarian stimulation.; ; Inclusion Criteria; Patients may be included in the study only if they meet all of the following criteria:; a. Signed and dated written informed consent; b. Infertile female patients naïve to any FSH (r-hFSH, u-hFSH) or hMG treatment undergoing superovulation for ART and about to start first treatment with Ovaleap or Gonal-f for ovarian stimulation; c. A negative pregnancy test prior to treatment; ; Exclusion Criteria; Patients will be excluded from participating in this study if they meet any of the following criteria:; a. Primary ovarian failure; b. Ovarian enlargement or cyst not due to polycystic ovarian syndrome; c. Neoplasm (e.g. tumors of the ovary, breast, uterus, hypothalamus, or pituitary gland); d. Prior history of OHSS.; e. Prior history of any r-hFSH use (eg, Puregon, Ovaleap, Bemfola, Elonva and/or Gonal-f), u-hFSH (eg, Bravelle and/or Fostimon) and/or hMG (eg, Menopur); f. Known allergy or hypersensitivity to recombinant FSH preparations or one of their excipients; g. Gynecologic bleeding (haemorrhages) of unknown aetiology; h. Any other contra-indications to receive r-hFSH
• Age groups:
  Adults (18 to < 46 years)
• Estimated number of subjects:
  820

Study design details

• Main study objective:
  The primary objective of the study is to assess the safety of Ovaleap compared to Gonal-f in one treatment cycle with respect to the incidence rates of OHSS in infertile women undergoing super-ovulation for assisted reproductive technologies (ART).
• Outcomes:
  Primary endpoint: OHSS, • Severity grade of OHSS (WHO Scientific Group classification 1973)• Adverse events/adverse drug reactions
• Data analysis plan:
  Descriptive summary statistics (including number of patients, mean, standard deviation, median, minimum, and maximum for continuous variables, and number and percentage of patients per category for categorical variables) will be provided for all variables. The primary objective of the study is to compare the incidence rate of OHSS in both Ovaleap and Gonal-f groups. The incidence rate of OHSS in both groups (along with the 95% CI) and the difference in OHSS incidence (Ovaleap - Gonal-f) along with the two-sided 95% CI will be calculated. In addition, a logistic regression model will be constructed to estimate the effect of age, country, and other baseline variables on the OHSS rate.