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CompletedNCT01408615Updated Feb 3, 2022

A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)

An observational study in Infertility, Female, sponsored by Organon and Co. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by Organon and Co · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
472
Sex
Female
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Study 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 reproductive technology (ART) program.

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Conditions studied

  • Infertility, Female
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 472 is above the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women participating in an ART program consisting of COS in combination with a GnRH antagonist in a general clinical setting.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
472 participants (actual)
Patient registry
No

Groups and cohorts

  • All Enrolled Participants

    Women undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program.

    Drug: corifollitropin alfa

Interventions

  • Drugcorifollitropin alfa

    100 or 150 microgram single subcutaneous injection

    Also known as: Elonva

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What researchers measure

Primary outcomes

  1. Number of Oocytes Retrieved

    Time frame: At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection)

  2. Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)

    Time frame: During treatment and up to 30 days after cessation of treatment

  3. Number of Participants who report an serious adverse event (SAE)

    Time frame: During treatment and up to 30 days after cessation of treatment

  4. Number of Participants who report an adverse event (AE)

    Time frame: During treatment and up to 30 days after cessation of treatment

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01408615
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Aug 3, 2011
Start date
Sep 20, 2011
Primary completion
Nov 18, 2016
Completion
Nov 18, 2016
Last update
Feb 3, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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