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

January 20, 2023 updated by: Ferring Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment duration with MENOPUR (complete patient population and subgroups analysis)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: At the day of the first MENOPUR injection during the ovarian stimulation treatment (during 20 days) in 2018
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)
Time Frame: At the day of the last MENOPUR injection during the ovarian stimulation treatment (during 20 days) in 2018
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)
Time Frame: From day 1 up to day 20 of MENOPUR stimulation during 2018
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)
Time Frame: From day 1 up to day 20 of MENOPUR stimulation during 2018
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)
Time Frame: From day 1 up to day 20 of MENOPUR stimulation during 2018
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)
Time Frame: Up to the end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: At the day of the first additional gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
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)
Time Frame: At the day of the last additional gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
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)
Time Frame: At the day of the first added gonadotropin (s) injection during the ovarian stimulation treatment (during 20 days) in 2018
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)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: Treatment prescription day with additional gonadotropin (s) up to the end of stimulation treatment (up to 20 days) during 2018
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)
Time Frame: At consultation visit where the LH surge suppression protocol is decided during 2018
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)
Time Frame: At the day of the first GnRH administration during the ovarian stimulation treatment (during 20 days) in 2018
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)
Time Frame: At the day of the last GnRH administration during the ovarian stimulation treatment (during 20 days) in 2018
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)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: At consultation visit where the triggering of follicle maturation is decided during 2018
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)
Time Frame: At the day of administration during 2018
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)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2018
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)
Time Frame: From ovum pick-up (OPU) day up to the end of luteal phase support during 2018
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved (complete patient population and subgroups analysis)
Time Frame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
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)
Time Frame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
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)
Time Frame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
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)
Time Frame: 2 weeks after embryo transfer
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)
Time Frame: At delivery
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)
Time Frame: At delivery
Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.
At delivery
Live birth parameter: gender (complete patient population and subgroups analysis)
Time Frame: At delivery
Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.
At delivery
Live birth parameter: weight (complete patient population and subgroups analysis)
Time Frame: At delivery
Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.
At delivery
Percentage of pregnancy loss (complete patient population and subgroups analysis)
Time Frame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
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)
Time Frame: 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
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)
Time Frame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
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)
Time Frame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
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)
Time Frame: Treatment prescription day with MENOPUR (during 2018) up to the delivery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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