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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01408615
First received: June 2, 2011
Last updated: August 12, 2016
Last verified: August 2016
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: January 2017
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   Child, Adult, Senior
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
  • Pregnancy
  • Polycystic ovarian syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 4130
Contact: Jongho Ahn    82-2-331-2000 2015      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01408615     History of Changes
Other Study ID Numbers: P08165 
Study First Received: June 2, 2011
Last Updated: August 12, 2016
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 December 06, 2016