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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Infertility, Female
• Intervention / Treatment: Other: MENOPUR Cohort

• Study Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Tel-aviv, Israel
    • Assuta Medical Center Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Live birth rate (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At delivery
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
Live birth parameter: gender (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At delivery
Live birth parameter: weight (complete patient population and subgroups analysis)	Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.	At delivery
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: MENOPUR
• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Menotropins
• Other Study ID Numbers: 000395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No