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A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165 AM1)

This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01408615
First received: June 2, 2011
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Infertility, Female
 Drug: corifollitropin alfa

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Oocytes Retrieved [ Time Frame: At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection) ] [ Designated as safety issue: No ]
  • Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: During treatment and up to 30 days after cessation of treatment ] [ Designated as safety issue: Yes ]
  • Number of Participants who report an serious adverse event (SAE) [ Time Frame: During treatment and up to 30 days after cessation of treatment ] [ Designated as safety issue: Yes ]
  • Number of Participants who report an adverse event (AE) [ Time Frame: During treatment and up to 30 days after cessation of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3600
Study Start Date: September 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders 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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408615

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Yong Soo (STEVE) Kim     82 2 331 2014        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01408615     History of Changes
Other Study ID Numbers: P08165
Study First Received: June 2, 2011
Last Updated: March 27, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on May 19, 2013