Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Infertility	Drug: Arvekap 0.1 mg (Triptorelin, Ipsen, France) Drug: Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)	Phase IV

MedlinePlus related topics:

Infertility

Drug Information available for:

Triptorelin Triptorelin pamoate Gonadorelin Gonadorelin hydrochloride LH-RH Ganirelix acetate Ganirelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Eugonia:

Primary Outcome Measures:

Ongoing pregnancy per embryo transfer

Secondary Outcome Measures:

Biochemical pregnancy per embryo transfer
Clinical pregnancy per embryo transfer
Embryological data

Estimated Enrollment:	300
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417183

Contacts


Contact: Tryfon Lainas, PhD	00302107236333	ivf@eugonia.com.gr

Locations


Greece
	Eugonia	Recruiting
	Athens, Greece, 11528
	Contact: Tryfon Lainas, PhD 00302107236333 ivf@eugonia.com.gr

Sponsors and Collaborators

Eugonia

Investigators


Principal Investigator:	Tryfon Lainas, PhD	Eugonia

More Information

Publications:

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.

Study ID Numbers:	long vs flexible
First Received:	December 22, 2006
Last Updated:	December 28, 2006
ClinicalTrials.gov Identifier:	NCT00417183
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Eugonia:

GnRH antagonist

GnRH agonist

Long protocol

Flexible

Study placed in the following topic categories:

Genital Diseases, Female

Deslorelin

Infertility

Ganirelix

Triptorelin

Genital Diseases, Male

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Contraceptive Agents

Therapeutic Uses

Physiological Effects of Drugs

Contraceptive Agents, Female

Enzyme Inhibitors

Reproductive Control Agents

Luteolytic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Eugonia
Information provided by:	Eugonia
ClinicalTrials.gov Identifier:	NCT00417183