Infertility, FemaleNCT01408615
A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
An observational study of Infertility, Female, run by Organon and Co.
Trial summary
This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for the development of multiple follicles in an assisted… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- corifollitropin alfa
- Type of treatment
- Injection or infusion
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2011to 18 Nov 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women participating in an ART program consisting of COS in combination with a GnRH antagonist in a general clinical setting.
Who may be able to join
- Women with an indication for COS prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who meet the criteria as mentioned in the current Korean ELONVA local label
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Primary ovarian failure
- Ovarian cysts or enlarged ovaries
- A history of OHSS
Show all 12Show fewer
- A previous COS cycle that resulted in more than 30 follicles ≥ 11 mm measured by ultrasound examination
- Basal antral follicle count > 20
- Fibroid tumors of the uterus incompatible with pregnancy
- Malformations of the reproductive organs incompatible with pregnancy
- Pregnancy
- Polycystic ovarian syndrome
About this study
Official title: Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of ELONVA in Usual Practice
This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for the development of multiple follicles in an assisted reproductive technology (ART) program.
- Conditions
- Infertility, Female
- Being tested
- corifollitropin alfa
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corifollitropin alfaDrug
Also called Elonva
100 or 150 microgram single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| All Enrolled Participants | Women undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program. Receives: Drug: corifollitropin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved
Measured: At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection)
Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)
Measured: During treatment and up to 30 days after cessation of treatment
Number of Participants who report an serious adverse event (SAE)
Measured: During treatment and up to 30 days after cessation of treatment
Number of Participants who report an adverse event (AE)
Measured: During treatment and up to 30 days after cessation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study start20 Sep 2011
- Primary completion18 Nov 2016
- Study completion18 Nov 2016
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
- Prospective
- Enrolment
- 472 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
- NCT01408615
- Sponsor's protocol ID
- P08165
- Status last verified
- Feb 2022
- First submitted
- 2 Jun 2011
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of ELONVA in Usual Practice
- ClinicalTrials.gov ID
- NCT01408615
- Acronym / sponsor ID
- P08165
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2011 (actual)
- Primary completion
- 18 Nov 2016 (actual)
- Study completion
- 18 Nov 2016 (actual)
- First posted
- 3 Aug 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.
This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for the development of multiple follicles in an assisted reproductive technology (ART) program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Enrolled Participants | – | Drug: corifollitropin alfaWomen undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women participating in an ART program consisting of COS in combination with a GnRH antagonist in a general clinical setting.
Key inclusion criteria (1 listed)
- Women with an indication for COS prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who meet the criteria as mentioned in the current Korean ELONVA local label
Key exclusion criteria (12 listed)
- Hypersensitivity to the active substance or to any of the excipients
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Primary ovarian failure
- Ovarian cysts or enlarged ovaries
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 |
|---|---|---|
| corifollitropin alfaAlso: Elonva100 or 150 microgram single subcutaneous injection | Drug | All Enrolled Participants |
Primary outcome
Number of Oocytes Retrieved
Time frame: At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection)
Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: During treatment and up to 30 days after cessation of treatment
Number of Participants who report an serious adverse event (SAE)
Time frame: During treatment and up to 30 days after cessation of treatment
Number of Participants who report an adverse event (AE)
Time frame: During treatment and up to 30 days after cessation of treatment
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 Feb 2022.
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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 Infertility, Female, 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 12 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 Feb 2022. 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 Oocytes Retrieved (time frame: At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection)). The study lists 4 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 Feb 2022.