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

Non-interventional study

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

Study drug and medical condition

• Name of medicine:
  PERGOVERIS
• Name of medicine, other:
  follitropin alfa / lutropin 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 6 months prior to signing of ICF ; 4. Use of Pergoveris (r-hFSH:r-hLH 2:1) from Day 1 of the OS cycle ; 5. Plan to use of GnRH analog to prevent premature LH surge ; 6. Plan to use of luteal phase support with progesterone supplementation (oral, vaginal, and/or intramuscular) ; 7. Stimulation started after date of local EC approval ; ;
• Special population of interest:
  Women of childbearing potential not using contraception
• Estimated number of subjects:
  1500

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 patients’ 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 6 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. Furthermore, for a visual description, histograms will be used to describe the distribution of the variables. ; • 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). ; ; In addition, event rates (with 95% CI) will be estimated per initiated cycle, OPU, and embryo transfer. Abortion rate and ectopic pregnancy rate will be estimated per 100 clinical pregnancies. ;