Study Stopped
Based on company decision to close the project
Retrospective Analysis of Real-world Data From Medical Records on the Use of MENOPUR for Infertility Treatment
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJanuary 25, 2023
June 1, 2022
1 year
March 10, 2021
January 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (25)
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 Outcomes (13)
Number of oocytes retrieved (complete patient population and subgroups analysis)
Treatment prescription day with MENOPUR (during 2018) up to the delivery
Number of fresh or frozen embryo transfer (complete patient population and subgroups analysis)
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)
Treatment prescription day with MENOPUR (during 2018) up to the delivery
Pregnancy rate (complete patient population and subgroups analysis)
2 weeks after embryo transfer
Live birth rate (complete patient population and subgroups analysis)
At delivery
- +8 more secondary outcomes
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Consecutive adult females who underwent ART treatment with MENOPUR for ovarian stimulation in 2018
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuta Medical Center Ltd
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 24, 2021
Study Start
September 1, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
January 25, 2023
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
U.S. National Library of Medicine \| U.S. National Institutes of Health \| U.S. Department of Health \& Human Services