Retrospective Analysis of Real-world Data From Medical Records on the Use of MENOPUR for Infertility Treatment

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04814940
• Other study ID #: 000395
• Status: Withdrawn
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: June 2022
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Other:
• MENOPUR Cohort
Non-interventional All directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study take place.

Locations

Country	Name	City	State
Israel	Assuta Medical Center Ltd	Tel-aviv

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment duration with MENOPUR (complete patient population and subgroups analysis)	Duration of treatment (in days) with MENOPUR for complete patient population and subgroup of patients will be reported. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Day of MENOPUR stimulation start (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At the day of the first MENOPUR injection during the ovarian stimulation treatment (during 20 days) in 2018
Primary	Day of MENOPUR stimulation end (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At the day of the last MENOPUR injection during the ovarian stimulation treatment (during 20 days) in 2018
Primary	Starting dose of MENOPUR prescribed in IU (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	From day 1 up to day 20 of MENOPUR stimulation during 2018
Primary	Dose Adjustment of MENOPUR in IU (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	From day 1 up to day 20 of MENOPUR stimulation during 2018
Primary	Total dose of MENOPUR (complete patient population and subgroup analysis)	Defined as total dose of MENOPUR used during the treatment duration. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	From day 1 up to day 20 of MENOPUR stimulation during 2018
Primary	Addition of gonadotropin (s) in case of mixed ovarian stimulation treatment (complete patient population and subgroup analysis)	In case of mixed treatments with gonadotropin (s) at the discretion of the investigator, addition of gonadotropin (s) will be reported. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to the end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Mixed treatment duration with added gonadotropin (s) (complete patient population and subgroup analysis)	In case of mixed treatments with gonadotropin (s), total duration with added gonadotropin (s) will be reported. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Day of treatment with additional gonadotropin (s) start (complete patient population and subgroups analysis)	The time point of the start of the stimulation is decided at the discretion of the investigator. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At the day of the first additional gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
Primary	Day of treatment with additional gonadotropin (s) end (complete patient population and subgroups analysis)	The time point of the end of the stimulation is decided at the discretion of the investigator. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At the day of the last additional gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
Primary	Starting dose of added gonadotropin (s) (complete patient population and subgroup analysis)	In case of mixed treatments with gonadotropin (s), starting dose of added gonadotropin (s) will be reported. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At the day of the first added gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
Primary	Dose adjustment of added gonadotropin (s) (complete patient population and subgroup analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Total dose of additional gonadotropin (s) (complete patient population and subgroup analysis)	Defined as total dose of additional gonadotropin (s) used during the treatment duration. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Treatment prescription day with additional gonadotropin (s) up to the end of stimulation treatment (up to 20 days) during 2018
Primary	Type of gonadotropin releasing hormone (GnRH) used for Lutenizing Hormone(LH) surge suppression (complete patient population and subgroups analysis)	Defined as a choice between GnRH agonist and GnRH antagonist. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At consultation visit where the LH surge suppression protocol is decided during 2018
Primary	Day of LH surge suppression protocol start (complete patient population and subgroups analysis)	The time point of the start of LH surge suppression is decided at the discretion of the investigator. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At the day of the first GnRH administration during the ovarian stimulation treatment (during 20 days) in 2018
Primary	Day of LH surge suppression protocol end (complete patient population and subgroups analysis)	The time point of the end of LH surge suppression is decided at the discretion of the investigator. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At the day of the last GnRH administration during the ovarian stimulation treatment (during 20 days) in 2018
Primary	Total number of follicles >=12 millimeter (mm) at the end of stimulation (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Circulating levels of progesterone (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Circulating levels of estrogen (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Type of drug used for the triggering of follicle maturation (complete patient population and subgroups analysis)	Decided at the discretion of the investigator. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At consultation visit where the triggering of follicle maturation is decided during 2018
Primary	Date of administration of human chorionic gonadotropin (hCG) and/or GnRH for follicle maturation (complete patient population and subgroups analysis)	Date when the investigator decides to trigger the final follicle maturation. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At the day of administration during 2018
Primary	Endometrium description: endometrial thickness (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Endometrium description: triple line visible (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Endometrium description: poorly defined central line (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
Primary	Type of drug used for Luteal phase support (complete patient population and subgroups analysis)	Decided at the discretion of the investigator between progesterone, oestrogen and hCG. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	From ovum pick-up (OPU) day up to the end of luteal phase support during 2018
Secondary	Number of oocytes retrieved (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Treatment prescription day with MENOPUR (during 2018) up to the delivery
Secondary	Number of fresh or frozen embryo transfer (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Treatment prescription day with MENOPUR (during 2018) up to the delivery
Secondary	Quality and number of embryo(s) transferred in fresh and frozen cycles (complete patient population and subgroups analysis)	Total number of embryo(s) and total number of good-quality embryo (s) transferred will be reported. Embryo quality is defined at the discretion of the investigator according to their routine practice. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Treatment prescription day with MENOPUR (during 2018) up to the delivery
Secondary	Pregnancy rate (complete patient population and subgroups analysis)	Defined as positive pregnancy 2 weeks after embryo transfer. Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	2 weeks after embryo transfer
Secondary	Live birth rate (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At delivery
Secondary	Live birth parameter: gestation duration (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At delivery
Secondary	Live birth parameter: gender (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At delivery
Secondary	Live birth parameter: weight (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At delivery
Secondary	Percentage of pregnancy loss (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Treatment prescription day with MENOPUR (during 2018) up to the delivery
Secondary	Number of patients with cycle cancellation before and after the ovum pick-up (OPU) (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	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
Secondary	Percentage of preventive measures for early ovarian hyper-stimulation syndrome (OHSS) (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Treatment prescription day with MENOPUR (during 2018) up to the delivery
Secondary	Rate of OHSS occurence (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Treatment prescription day with MENOPUR (during 2018) up to the delivery
Secondary	Rate of early and late OHSS (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	Treatment prescription day with MENOPUR (during 2018) up to the delivery