A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: highly purified human chorionic gonadotropin (Drug); recombinant human chorionic gonadotropin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
Overall contact:
Clinical Development Support, Email: DK0-Disclosure@ferring.com
Summary
This trial is investigating the efficacy and safety of highly purified human chorionic
gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of
final follicular maturation in women undergoing controlled ovarian stimulation
Clinical Details
Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of oocytes retrieved
Secondary outcome: Number of metaphase II oocytesNumber of fertilised (2 pronuclei (2PN)) oocytes Positive beta unit of human chorionic gonadotropin (βhCG) rate Clinical pregnancy rate Frequency of adverse events Intensity of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 39 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Pre-menopausal females between the ages of 18 and 39 years
- Documented history of infertility
- Body mass index (BMI) between 17. 5 and 32. 0 kg/m2
- Regular menstrual cycles
Exclusion Criteria:
- Known endometriosis stage III and IV
- Known polycystic ovarian syndrome (PCOS)
- History of recurrent miscarriage
- History of more than three previous controlled ovarian stimulation cycles
Locations and Contacts
Clinical Development Support, Email: DK0-Disclosure@ferring.com
Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country), São Paulo, Brazil; Not yet recruiting
Additional Information
Starting date: December 2015
Last updated: May 20, 2015
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