Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation

Infertility Clinical Trial

Official title:

Randomized Controlled Trial Comparing the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation in Normal Responders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00417183
• Other study ID #: long vs flexible
• Status: Recruiting
• Phase: Phase 4
• First received: December 22, 2006
• Last updated: December 28, 2006
• Start date: September 2005
• Est. completion date: June 2007

Study information

• Verified date: December 2006
• Source: Eugonia
• Contact: Tryfon Lainas, PhD
• Phone: 00302107236333
• Email: ivf[@]eugonia.com.gr
• 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 efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment.

Description:

The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF. The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success. More recently, on the other hand, GnRH antagonist provide a new promising approach for endogenous gonadotrophin suppression by blocking the GnRH receptor. There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols.

COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

Inclusion Criteria:

• Age 18-39 years

• Body mass index 18-29 kg/m2

• Menstrual cycle from 24-35 days

• Normal basal FSH (<10 IU/ml)

• Normal basal LH (<10 IU/ml)

• Normal basal estradiol (<80 pg/ml)

Exclusion Criteria:

• Poor responder patients

• Polycystic ovaries

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:
• Arvekap 0.1 mg (Triptorelin, Ipsen, France)

• Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)

Locations

Country	Name	City	State
Greece	Eugonia	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Lainas T, Zorzovilis J, Petsas G, Stavropoulou G, Cazlaris H, Daskalaki V, Lainas G, Alexopoulou E. In a flexible antagonist protocol, earlier, criteria-based initiation of GnRH antagonist is associated with increased pregnancy rates in IVF. Hum Reprod. 2005 Sep;20(9):2426-33. Epub 2005 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy per embryo transfer
Secondary	Biochemical pregnancy per embryo transfer
Secondary	Clinical pregnancy per embryo transfer
Secondary	Embryological data