Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction

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

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-availability Study

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.

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

Eugonia, Athens 11528, Greece

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.

Starting date: June 2004
Ending date: December 2006
Last updated: January 4, 2007