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

Infertility Clinical Trial

Official title:

Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00415766
• Other study ID #: ovitrelle vs pregnyl
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 22, 2006
• Last updated: January 18, 2016
• Start date: June 2013
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: Eugonia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• rHCG 250ug
Injection of 250 ug Ovitrelle to trigger final oocyte maturation
• uHCG 5000 IU
Injection of 5000 IU Pregnyl to trigger final oocyte maturation
• uHCG 7500 IU
Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Locations

Country	Name	City	State
Greece	Eugonia	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of mature oocytes	Percentage MII/COCs	Day of oocyte retrieval (Day 0)	No
Secondary	Positive test per embryo transfer		15 days post oocyte retrieval	No
Secondary	Clinical pregnancy per embryo transfer		7 weeks of gestation	No
Secondary	Ongoing pregnancy per embryo transfer		12 weeks of gestation	No
Secondary	Level of serum hCG on day of oocyte retrieval		Day of oocyte retrieval	No
Secondary	Number of oocytes (COC) retrieved		Day of oocyte retrieval	No
Secondary	Number of mature oocytes (MII)		Day of oocyte retrieval	No
Secondary	Oocyte retrieval rate	Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation	Day of oocyte retrieval (Day 0)	No
Secondary	Incidence of severe early OHSS		up to Day 5 post oocyte retrieval	Yes