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Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction

Information source: Eugonia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: ovidrele, pregnyl (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Eugonia

Official(s) and/or principal investigator(s):
Tryfon Lainas, PhD, Principal Investigator, Affiliation: Eugonia

Summary

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.

Clinical Details

Official title: Recombinant hCG (Ovidrel) Vesrus Urinary hCG (Pregnyl) for Ovulation Induction in Normal Responders

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Level of hCG on day of oocyte retrieval

Secondary outcome:

Biochemical pregnancy per embryo transfer

Clinical pregnancy per embryo transfer

Ongoing pregnancy per embryo transfer

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

Minimum age: 18 Years. Maximum age: 39 Years. Gender(s): Female.

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

Locations and Contacts

Eugonia, Athens 11528, Greece
Additional Information

Related 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. Update in: Cochrane Database Syst Rev. 2011;(4):CD003719.

Starting date: June 2004
Last updated: January 4, 2007

Page last updated: August 23, 2015

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