MS200061_0073: Pergoveris patients’ profile and outcome response measurement in IVF/ICSI autologous cycles (PERFORM)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  A multi-center and multi-country, prospective, observational study.

Study drug and medical condition

• Medicinal product name:
  PERGOVERIS
• Medicinal product name, other:
  follitropin alfa / lutropin alfa
• Study drug International non-proprietary name (INN) or common name:
  LUTROPIN ALFA

  FOLLITROPIN ALFA
• Anatomical Therapeutic Chemical (ATC) code:
  (G03GA07) lutropin alfa

  lutropin alfa

  (G03GA05) follitropin alfa

  follitropin alfa

Population studied

• Short description of the study population:
  The study population will be identified according to the inclusion and exclusion criteria below. Participants are only eligible to participate in the study for 1 OS cycle. ; Participants are eligible to be included in the study only if they meet all the following criteria: ; 1. Age 18-45 (inclusive) years at consent ; 2. 1st, 2nd, or 3rd OS cycle for ART treatment ; 3. AMH levels available in the 12 months prior to signing of ICF or a planned assessment of AMH levels before Day 1 of OS; 4. Use of Pergoveris (r-hFSH:r-hLH 2:1) from Day 1 of the OS cycle ; 5. Plan to use of GnRH analog (agonist or antagonist) to prevent premature LH surge ; 6. Plan to use of luteal phase support with progesterone supplementation (oral, vaginal, subcutaneous, and/or intramuscular) ; 7. Initiation of OS cycle with Pergoveris within 12 weeks from ICF date; 8. Female participant and male partner are willing and able to provide written informed consent; 9. Stimulation started after date of local EC approval ;
• Special population of interest:
  Women of childbearing potential not using contraception
• Estimated number of subjects:
  1.500

Study design details

• Study design:
  This study is a multi-center and multi-country, prospective, observational study aimed at characterizing the patient population undergoing OS with Pergoveris in autologous IVF/ICSI cycles, along with assessing the outcomes of this stimulation protocol.
• Main study objective:
  To describe participants’ profiles for whom r-hFSH/r-hLH combination (Pergoveris) is administered in a real-world clinical setting, where treatment with ART is provided as part of routine care
• Outcomes:
  Baseline characteristics ; • Age ; • Male partner age ; • Ethnicity ; • Race ; • Height ; • Weight ; • BMI ; • Lifestyle factors ; • Medical history ; • Comorbidities ; • Infertility diagnosis ; • Duration of infertility ; • 1st, 2nd, or 3rd OS cycle for ART treatment ; • Baseline hormone analysis ; • Reproductive history ; • AMH levels in the previous 12 months ; • AFC data in previous 6 months, as available ; • AFC data for current OS cycle, as available ; • Male partner spermiogram in previous 6 months, as available ; • Previous OS cycle for IVF/ICSI and outcome information (if applicable)
• Data analysis plan:
  No hypothesis will be tested in the study. Descriptive statistics will be presented as such: ; • For continuous variables: case count, mean, SD, mode, minimum and maximum values, median and first quartile (Q1) – third quartile (Q3). Descriptive results will be reported with appropriate decimal places (e.g. mean will be reported to the same decimal place as raw data and SD will be reported with 1 more decimal place than mean). The presence and number of missing data will be reported, and descriptive statistics will be calculated from the values provided (i.e. non-missing values) only. ; • Categorical variables will be summarized using counts and percentages. The modality “missing data” will be considered as a possible level, with its size and its proportion calculated relative to the total number of study participants at the corresponding time frame, if not specified differently. Percentages of the other modalities will be calculated relative to the total (i.e. non-missing plus missing). Descriptive results for means (i.e. for continuous variables) will be reported with appropriate decimal places (e.g. mean will be reported to the same decimal place as raw data and SD will be reported with 1 more decimal place than mean). ; ; • 95% CI will also be provided for rates (e.g. cancellation rate, abortion rate, ectopic pregnancy rate, miscarriage rate, live birth rate).; ; • Analyses will be conducted overall and by country.; ;