Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eugonia
ClinicalTrials.gov Identifier:
NCT00415766
First received: December 22, 2006
Last updated: January 18, 2016
Last verified: January 2016
  Purpose
The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.

Condition Intervention Phase
Infertility
Drug: rHCG 250ug
Drug: uHCG 5000 IU
Drug: uHCG 7500 IU
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders

Resource links provided by NLM:


Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Percentage of mature oocytes [ Time Frame: Day of oocyte retrieval (Day 0) ] [ Designated as safety issue: No ]
    Percentage MII/COCs


Secondary Outcome Measures:
  • Positive test per embryo transfer [ Time Frame: 15 days post oocyte retrieval ] [ Designated as safety issue: No ]
  • Clinical pregnancy per embryo transfer [ Time Frame: 7 weeks of gestation ] [ Designated as safety issue: No ]
  • Ongoing pregnancy per embryo transfer [ Time Frame: 12 weeks of gestation ] [ Designated as safety issue: No ]
  • Level of serum hCG on day of oocyte retrieval [ Time Frame: Day of oocyte retrieval ] [ Designated as safety issue: No ]
  • Number of oocytes (COC) retrieved [ Time Frame: Day of oocyte retrieval ] [ Designated as safety issue: No ]
  • Number of mature oocytes (MII) [ Time Frame: Day of oocyte retrieval ] [ Designated as safety issue: No ]
  • Oocyte retrieval rate [ Time Frame: Day of oocyte retrieval (Day 0) ] [ Designated as safety issue: No ]
    Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation

  • Incidence of severe early OHSS [ Time Frame: up to Day 5 post oocyte retrieval ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: June 2013
Estimated Study Completion Date: July 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rHCG 250 ug
Injection of 250 ug Ovitrelle to trigger final oocyte maturation
Drug: rHCG 250ug
Injection of 250 ug Ovitrelle to trigger final oocyte maturation
Other Name: Ovitrelle
Active Comparator: uHCG 5000 IU
Injection of 5000 IU Pregnyl to trigger final oocyte maturation
Drug: uHCG 5000 IU
Injection of 5000 IU Pregnyl to trigger final oocyte maturation
Other Name: Pregnyl 5000 IU
Active Comparator: uHCG 7500 IU
Injection of 7500 IU Pregnyl to trigger final oocyte maturation
Drug: uHCG 7500 IU
Injection of 7500 IU Pregnyl to trigger final oocyte maturation
Other Name: Pregnyl 7500 IU

Detailed Description:
Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.
  Eligibility

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 14 follicles >11mm on the day of triggering final oocyte maturation
  • Pretreated with GnRH antagonist protocol

Exclusion Criteria:

  • Poor responders
  • Women with 25 or more follicles on the day of trigger
  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: NCT00415766

Locations
Greece
Eugonia
Athens, Greece, 11528
Sponsors and Collaborators
Eugonia
Investigators
Principal Investigator: Tryfon Lainas, PhD Eugonia
  More Information

Publications:
Responsible Party: Eugonia
ClinicalTrials.gov Identifier: NCT00415766     History of Changes
Other Study ID Numbers: ovitrelle vs pregnyl 
Study First Received: December 22, 2006
Last Updated: January 18, 2016
Health Authority: Greece: National Organization of Medicines

Keywords provided by Eugonia:
recombinant hCG
urinary hCG

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016