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 2014 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: March 25, 2014
Last verified: March 2014
  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: 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: Gary Jankelowitz    61 2 8988 8246      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

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: March 25, 2014
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 April 15, 2014