Clinical trial NCT04814940: Retrospective Analysis of Real-world Data From Medical Records on the Use of MENOPUR for Infertility Treatment
Official title: Retrospective Analysis of Real-world Data From Medical Records on the Use of Gonadotropin for Infertility Treatment to Describe the Treatment Patterns and to Understand the Clinical Impact
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility, Female
Keywords: MENOPUR
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women, fitting the inclusion/exclusion criteria, who were prescribed MENOPUR in 2018 at for controlled ovarian stimulation in a treatment of infertility with In Vitro Fertilisation (IVF) or Intra-Cytoplasmic Sperm Injection (ICSI) will be included in this study.

Brief summary: The purpose of this retrospective observational study is to describe the treatment patterns with MENOPUR and to understand the clinical impact for patients that underwent infertility treatment under real-world setting.

The primary objective is to describe the treatment patterns for the general population and for selected patient profiles.


Eligibility criteria: Inclusion Criteria:

* Consecutive adult females who underwent ART treatment with MENOPUR for ovarian stimulation in 2018

Exclusion Criteria:

* None

Primary outcomes:
measure: Treatment duration with MENOPUR (complete patient population and subgroups analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Day of MENOPUR stimulation start (complete patient population and subgroups analysis)
timeFrame: At the day of the first MENOPUR injection during the ovarian stimulation treatment (during 20 days) in 2018
measure: Day of MENOPUR stimulation end (complete patient population and subgroups analysis)
timeFrame: At the day of the last MENOPUR injection during the ovarian stimulation treatment (during 20 days) in 2018
measure: Starting dose of MENOPUR prescribed in IU (complete patient population and subgroups analysis)
timeFrame: From day 1 up to day 20 of MENOPUR stimulation during 2018
measure: Dose Adjustment of MENOPUR in IU (complete patient population and subgroups analysis)
timeFrame: From day 1 up to day 20 of MENOPUR stimulation during 2018
measure: Total dose of MENOPUR (complete patient population and subgroup analysis)
timeFrame: From day 1 up to day 20 of MENOPUR stimulation during 2018
measure: Addition of gonadotropin (s) in case of mixed ovarian stimulation treatment (complete patient population and subgroup analysis)
timeFrame: Up to the end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Mixed treatment duration with added gonadotropin (s) (complete patient population and subgroup analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Day of treatment with additional gonadotropin (s) start (complete patient population and subgroups analysis)
timeFrame: At the day of the first additional gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
measure: Day of treatment with additional gonadotropin (s) end (complete patient population and subgroups analysis)
timeFrame: At the day of the last additional gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
measure: Starting dose of added gonadotropin (s) (complete patient population and subgroup analysis)
timeFrame: At the day of the first added gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
measure: Dose adjustment of added gonadotropin (s) (complete patient population and subgroup analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Total dose of additional gonadotropin (s) (complete patient population and subgroup analysis)
timeFrame: Treatment prescription day with additional gonadotropin (s) up to the end of stimulation treatment (up to 20 days) during 2018
measure: Type of gonadotropin releasing hormone (GnRH) used for Lutenizing Hormone(LH) surge suppression (complete patient population and subgroups analysis)
timeFrame: At consultation visit where the LH surge suppression protocol is decided during 2018
measure: Day of LH surge suppression protocol start (complete patient population and subgroups analysis)
timeFrame: At the day of the first GnRH administration during the ovarian stimulation treatment (during 20 days) in 2018
measure: Day of LH surge suppression protocol end (complete patient population and subgroups analysis)
timeFrame: At the day of the last GnRH administration during the ovarian stimulation treatment (during 20 days) in 2018
measure: Total number of follicles >=12 millimeter (mm) at the end of stimulation (complete patient population and subgroups analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Circulating levels of progesterone (complete patient population and subgroups analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Circulating levels of estrogen (complete patient population and subgroups analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Type of drug used for the triggering of follicle maturation (complete patient population and subgroups analysis)
timeFrame: At consultation visit where the triggering of follicle maturation is decided during 2018
measure: Date of administration of human chorionic gonadotropin (hCG) and/or GnRH for follicle maturation (complete patient population and subgroups analysis)
timeFrame: At the day of administration during 2018
measure: Endometrium description: endometrial thickness (complete patient population and subgroups analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Endometrium description: triple line visible (complete patient population and subgroups analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Endometrium description: poorly defined central line (complete patient population and subgroups analysis)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
measure: Type of drug used for Luteal phase support (complete patient population and subgroups analysis)
timeFrame: From ovum pick-up (OPU) day up to the end of luteal phase support during 2018
Secondary outcomes:
measure: Number of oocytes retrieved (complete patient population and subgroups analysis)
timeFrame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
measure: Number of fresh or frozen embryo transfer (complete patient population and subgroups analysis)
timeFrame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
measure: Quality and number of embryo(s) transferred in fresh and frozen cycles (complete patient population and subgroups analysis)
timeFrame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
measure: Pregnancy rate (complete patient population and subgroups analysis)
timeFrame: 2 weeks after embryo transfer
measure: Live birth rate (complete patient population and subgroups analysis)
timeFrame: At delivery
measure: Live birth parameter: gestation duration (complete patient population and subgroups analysis)
timeFrame: At delivery
measure: Live birth parameter: gender (complete patient population and subgroups analysis)
timeFrame: At delivery
measure: Live birth parameter: weight (complete patient population and subgroups analysis)
timeFrame: At delivery
measure: Percentage of pregnancy loss (complete patient population and subgroups analysis)
timeFrame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
measure: Number of patients with cycle cancellation before and after the ovum pick-up (OPU) (complete patient population and subgroups analysis)
timeFrame: From treatment prescription day with MENOPUR (during 2018) up to the OPU day during 2018 and from the OPU day during 2018 up to the delivery
measure: Percentage of preventive measures for early ovarian hyper-stimulation syndrome (OHSS) (complete patient population and subgroups analysis)
timeFrame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
measure: Rate of OHSS occurence (complete patient population and subgroups analysis)
timeFrame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
measure: Rate of early and late OHSS (complete patient population and subgroups analysis)
timeFrame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
Other outcomes:
Locations:
city: Tel-aviv
country: Israel
facility: Assuta Medical Center Ltd
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: