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

First Received on December 22, 2006. Last Updated on January 4, 2007 History of Changes

Sponsor:	Eugonia
Information provided by:	Eugonia
ClinicalTrials.gov Identifier:	NCT00415766

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 IV

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

Drug Information available for: Choriogonadotropin Alfa Chorionic gonadotropin

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:

Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis. Reprod Biol Endocrinol. 2006 Jul 18;4:38.

Al-Inany HG, Aboulghar M, Mansour R, Proctor M. Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003719. Review.

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 February 09, 2012