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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01408615
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment
Infertility, Female Drug: corifollitropin alfa

Study Type : Observational
Actual Enrollment : 472 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of ELONVA in Usual Practice
Actual Study Start Date : September 20, 2011
Actual Primary Completion Date : November 18, 2016
Actual Study Completion Date : November 18, 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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
100 or 150 microgram single subcutaneous injection
Other Name: Elonva

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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:

  • 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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01408615     History of Changes
Other Study ID Numbers: P08165
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female