Fertilization in VitroNCT01304511
Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®
An observational study of Fertilization in Vitro, run by Organon and Co.
Trial summary
The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fertilization in Vitro
- What is being tested?
- Orgalutran
- How many people
- 711 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Dec 2007
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Women undergoing COH for ART
Who may be able to join
- Must be undergoing COH for ART
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients
- Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue
- Moderate or severe impairment of renal or hepatic function
- Pregnancy or lactation
About this study
Official title: Post-Marketing Surveillance Orgalutran (Ganirelix)®
The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
- Conditions
- Fertilization in Vitro
- Being tested
- Orgalutran
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrgalutranDrug
Also called Ganirelix®
| Study group | Role | What they receive |
|---|---|---|
| Participants Treated | Women undergoing controlled ovarian COH for ART Receives: Drug: Orgalutran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved oocytes by COH based on Per stage approach
Measured: Baseline to End of Study
Number of Serious Adverse Events
Measured: Baseline to End of Study
Number of Unlabeled (Unexpected) Adverse Drug Reactions
Measured: Baseline to End of Study
Number of Labeled Adverse Drug Reactions
Measured: Baseline to End of Study
Number of Non-serious Adverse Events
Measured: Baseline to End of Study
Number of Adverse events by drug misuse/abuse or drug-drug interaction
Measured: Baseline to End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertilization in VitroStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304511
- Sponsor's protocol ID
- P08198
- Status last verified
- Apr 2024
- First submitted
- 24 Feb 2011
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance Orgalutran (Ganirelix)®
- ClinicalTrials.gov ID
- NCT01304511
- Acronym / sponsor ID
- P08198
- Conditions
- Fertilization in Vitro
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Feb 2011 (estimated)
- 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 post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Treated | – | Drug: OrgalutranWomen undergoing controlled ovarian COH for ART |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Women undergoing COH for ART
Key inclusion criteria (1 listed)
- Must be undergoing COH for ART
Key exclusion criteria (4 listed)
- Hypersensitivity to the active substance or to any of the excipients
- Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue
- Moderate or severe impairment of renal or hepatic function
- Pregnancy or lactation
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 |
|---|---|---|
| OrgalutranAlso: Ganirelix® | Drug | Participants Treated |
Primary outcome
Number of retrieved oocytes by COH based on Per stage approach
Time frame: Baseline to End of Study
Number of Serious Adverse Events
Time frame: Baseline to End of Study
Number of Unlabeled (Unexpected) Adverse Drug Reactions
Time frame: Baseline to End of Study
Number of Labeled Adverse Drug Reactions
Time frame: Baseline to End of Study
Number of Non-serious Adverse Events
Time frame: Baseline to End of Study
Number of Adverse events by drug misuse/abuse or drug-drug interaction
Time frame: Baseline to End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertilization in Vitro, run by Organon and Co.
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 4 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: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of retrieved oocytes by COH based on Per stage approach (time frame: Baseline to End of Study). The study lists 6 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 3 Apr 2024.