1. Study Objective: To evaluate the clinical pregnancy rate in South Korean female patients who received controlled ovarian hyperstimulation with recombinant follicle-stimulating hormone (rFSH), To evaluate the live birth rates, the number of retrieved oocytes, the number of mature oocytes, and the number of fertilized oocytes in South Korean female patients who received controlled ovarian hyperstimulation with recombinant follicle-stimulating hormone (rFSH),  To evaluate the safety (Ovarian hyperstimulation syndrome; OHSS) following the administration of rFSH in actual clinical practice (e.g. the incidence rate of OHSS, %)
Exploratory Objective, To explore the dosing regimen of rFSH (e.g. starting dose, dosing period, and total dose), To compare the dosing regimen of rFSH from this study with that from ESTHER-1 study
2. Study Design
Multicenter (two centers), retrospective observational chart review study
Collect the information of subjects who underwent in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) procedures with rFSH from January 2013 to December 2017 based on medical records, Screen the subjects who meet the inclusion/exclusion criteria of ESTHER-1 study and have AMH data available, Analyze the primary, secondary, and exploratory endpoints
3. Study Population: Subjects who received controlled ovarian hyperstimulation for assisted reproductive technology procedures such as IVF or ICSI with rFSH from January 2013 to December 2017 (60 months in total)
4.      
1) Medical records will be collected from subjects who received controlled ovarian hyperstimulation for assisted reproductive technology procedures such as IVF or ICSI with rFSH from January 2013 to December 2017 (60 months in total) in two local university hospitals.
Then, the medical records of subjects who meet the eligibility criteria of ESTHER-1 study will be screened.
2) Pregnancy outcomes (clinical pregnancy rate at 10~11 weeks and live birth rates) and the incidence rate of OHSS will be evaluated.
3) The dosing period, total dose, and starting dose of rFSH will be investigated, and the dose of follitropin delta will be predicted based on body weight and AMH levels.
5. Statistical Analysis
Estimates of efficacy endpoints will be presented with a 95% confidence interval (CI). Statistical associations between pregnancy/fertility variables and age, body weight, BMI, AMH concentrations, starting dose and total dose of rFSH will be analyzed. For univariate analysis, continuous variables will be tested using t-test or Mann-Whitney U test while categorical variables using Chi-square test, Fisher’s exact test, etc. A multivariate analysis will be made using logistic regression models.
Estimates of safety endpoints will be presented with a 95% CI. Statistical associations between safety outcomes and age, body weight, BMI, AMH concentrations, starting dose and total dose of rFSH will be analyzed by logistic regression. Clinical laboratory findings before and after dosing of rFSH will be summarized using descriptive statistics and statistical testing for a change in such findings will be conducted.
For an exploratory endpoint, comparison with ESTHER-1 will be performed using t-test.

Cohort/Group Label

who received controlled ovarian hyperstimulation for assisted reproductive technology procedures such as IVF or ICSI with rFSH

Cohort/Group Description

Medical records will be collected from subjects who received controlled ovarian hyperstimulation for assisted reproductive technology procedures such as IVF or ICSI with rFSH from January 2013 to December 2017 (60 months in total) in two local university hospitals. Then, the medical records of subjects who meet the eligibility criteria of ESTHER-1 study will be screened and Pregnancy outcomes (clinical pregnancy rate at 5-6 weeks and live birth rates) and the incidence rate of OHSS will be evaluated and the dosing period, total dose, and starting dose of rFSH will be investigated, and the dose of follitropin delta will be predicted based on body weight and AMH levels.

Not collect nor Archive

Subjects who received controlled ovarian hyperstimulation for assisted reproductive technology procedures such as IVF or ICSI with rFSH from January 2013 to December 2017 (60 months in total) and who are between the ages of 18 and 40 years at the time of controlled ovarian hyperstimulation.

Random sampling of Non-probability sampling becase collect the information of subjects who underwent IVF and ICSI procedures with rFSH from January 2013 to December 2017 based on medical records.

Gender

Age

Description

1. South Korean female patients who received controlled ovarian hyperstimulation for assisted reproductive technology procedures such as IVF or ICSI from January 2013 to December 2017.
    2. Women between the ages of 18 and 40 years at the time of controlled ovarian hyperstimulation.
    3. The first controlled ovarian hyperstimulation cycle.
    4. Body mass index between 17.5 and 32.0 kg/m2 (both inclusive).
    5. Subjects who received the procedure using a GnRH antagonist cycle.
    6. Subjects who received rFSH only.
    7. Controlled ovarian hyperstimulation cycle ≤ 20 days.
    8. Regular menstrual cycles of 24–35 days (both inclusive), presumed to be ovulatory.
    9. AMH levels available within 1 year prior to controlled ovarian hyperstimulation.

1. Known endometriosis stage III–IV.
    2. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy and before week 24 of pregnancy).
    3. Any known clinically significant systemic disease (e.g., insulin-dependent diabetes).
    4. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
    5. Any known endocrine or metabolic abnormalities.
    6. Known moderate or severe impairment of renal or hepatic function.
    7. Use of any rFSH preparations during the last 3 months before controlled  ovarian hyperstimulation.

Clinical pregnancy rate at 10~11 weeks, %

10~11 weeks after In Vitro Fertilization or Intra Cytoplasmic  Sperm Injection procedure

Live birth rates, The number of retrieved oocytes, The number of mature oocytes

before and after  IVF or ICSF procedure

Incidence rate of Ovarian Hyperstimulation Syndrome %, Hospitalization due to Ovarian Hyperstimulation Syndrome)

after  IVF or ICSF procedure