Post-marketing Observational Study to Characterize the Safety and Effectiveness Profile of Orgalutran® in Chinese Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproduction Techniques (MK-8761-050)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ORGALUTRAN
• Medical condition to be studied:
  Infertility

  Infertility female

Population studied

• Short description of the study population:
  Chinese women undergoing controlled overian hyperstimulation during an assisted reproductive technology receiving Orgalutran® for routine clinical practice in China.
• Age groups:
  Adults (18 to < 46 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Infertile female patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The main objective is to characterize the safety and effectiveness of Orgalutran in the Chinese population in the setting of routine clinical practice.
• Outcomes:
  Number of participants experiencing AEs and discontinuing study drug due to AEs, Serum concentration of LH at baseline, Days and total dosage of FSH administered, Number and size distribution of follicles, Number oocyte retrieved, Number embryos surviving at day of ET/embryos transferred, Proportion of women with positive pregnancy test/vital pregnancy, Proportion of women with a live-born baby.
• Data analysis plan:
  Safety endpoints will be summarized by count, point estimate and corresponding 95% confidence interval if applicable. The effective measures and subsequent clinical outcomes will be summarized by count, point estimate with standard deviation if applicable, and may be presented by age categories if applicable. Newborn measures will be summarized by count, point estimate with standard deviation, if applicable.

Documents

Study results

MK 8761-050 Synopsis Final Redaction