Infertility, FemaleNCT04814940
Retrospective Analysis of Real-world Data From Medical Records on the Use of MENOPUR for Infertility Treatment
An observational study of Infertility, Female, run by Ferring Pharmaceuticals at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- MENOPUR Cohort
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- Consecutive adult females who underwent ART treatment with MENOPUR for ovarian stimulation in 2018
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Infertility, Female
- Being tested
- MENOPUR Cohort
- Keywords
- MENOPUR
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MENOPUR CohortOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At delivery
Live birth parameter: gender (complete patient population and subgroups analysis)
Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.
Measured: At delivery
Live birth parameter: weight (complete patient population and subgroups analysis)
Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.
Measured: At delivery
Percentage of pregnancy loss (complete patient population and subgroups analysis)
Subgroup analysis refers to subgroups of patients stratified by patient baseline characteristics.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Treatment prescription day with MENOPUR (during 2018) up to the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Why it stopped: Based on company decision to close the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814940
- Sponsor's protocol ID
- 000395
- Status last verified
- Jun 2022
- First submitted
- 10 Mar 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: U.S. National Library of Medicine \| U.S. National Institutes of Health \| U.S. Department of Health \& Human Services
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04814940
- Acronym / sponsor ID
- 000395
- Conditions
- Infertility, Female
- Keywords
- MENOPUR
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Based on company decision to close the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Consecutive adult females who underwent ART treatment with MENOPUR for ovarian stimulation in 2018
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MENOPUR CohortNon-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. | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
13 secondary outcomes
Number of oocytes retrieved (complete patient population and subgroups analysis)
Time frame: 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
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
Pregnancy rate (complete patient population and subgroups analysis)
Time frame: 2 weeks after embryo transfer
Live birth rate (complete patient population and subgroups analysis)
Time frame: At delivery
Live birth parameter: gestation duration (complete patient population and subgroups analysis)
Time frame: At delivery
Live birth parameter: gender (complete patient population and subgroups analysis)
Time frame: At delivery
Live birth parameter: weight (complete patient population and subgroups analysis)
Time frame: 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
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
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
Rate of OHSS occurence (complete patient population and subgroups analysis)
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: Yes. U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health \& Human Services
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Ferring Pharmaceuticals at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.