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Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Eugonia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eugonia
ClinicalTrials.gov Identifier:
NCT00415766
First received: December 22, 2006
Last updated: January 4, 2007
Last verified: January 2007
History of Changes
  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: ovidrele, pregnyl
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recombinant hCG (Ovidrel) Vesrus Urinary hCG (Pregnyl) for Ovulation Induction in Normal Responders

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Level of hCG on day of oocyte retrieval

Secondary Outcome Measures:
  • Biochemical pregnancy per embryo transfer
  • Clinical pregnancy per embryo transfer
  • Ongoing pregnancy per embryo transfer

Estimated Enrollment: 200
Study Start Date: June 2004
Estimated Study Completion Date: December 2006
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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 18-29 kg/m2
  • Basal FSH <10IU/l
  • Basal LH <10 IU/l
  • Basal estradiol <80 pg/ml

Exclusion Criteria:

  • Poor responders
  • PCOS
  Contacts and Locations
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:

ClinicalTrials.gov Identifier: NCT00415766     History of Changes
Other Study ID Numbers: ovidrel vs pregnyl
Study First Received: December 22, 2006
Last Updated: January 4, 2007
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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013