Low Dose hCG in the Late Follicular Phase - Full Text View

Sponsored by:	Universitair Ziekenhuis Brussel
Information provided by:	Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:	NCT00750100

Purpose

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.

Condition	Intervention	Phase
Infertility	Drug: human chorionic gonadotropin Drug: recombinant gonadotropins	Phase IV

MedlinePlus related topics: Infertility

Drug Information available for: Choriogonadotropin Alfa Chorionic gonadotropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:

Number of oocytes in both treatment groups [ Time Frame: november 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group [ Time Frame: november 2008 ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	September 2007
Estimated Study Completion Date:	November 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.	Drug: recombinant gonadotropins 200 IU per day during controlled ovarian stimulation
B: Experimental Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.	Drug: human chorionic gonadotropin hCG 200IU in the late follicular phase

Eligibility

Ages Eligible for Study:	18 Years to 36 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

< 36 years on day of randomisation
FSH < 12 in the early follicular phase
Normal ultrasound scan
BMI between 18 and 29 (both inclusive)
Randomisation at outpatient clinic

Exclusion Criteria:

Endometriosis ≥ grade 3
PCO syndrome
Poor responder
Endocrine or metabolic abnormalities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750100

Locations

Belgium, Brussels
UZ Brussel
Laarbeeklaan 101, Brussels, Belgium, 1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

Principal Investigator:

Christophe Blockeel, MD

UZ Brussel, Centre for Reproductive Medicine, Brussels

More Information

Publications:

Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401.

Responsible Party:	Universitair Ziekenhuis Brussel ( Paul Devroey )
Study ID Numbers:	EC REF 2006-157
Study First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750100 History of Changes
Health Authority:	Belgium: Ethics Committee

Keywords provided by Universitair Ziekenhuis Brussel:

infertility
IVF
hCG

primary infertility
secondary infertility
patients requiring in-vitro fertilisation

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Neoplasm Metastasis
Chorionic Gonadotropin
Genital Diseases, Male

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Therapeutic Uses
Physiological Effects of Drugs

Reproductive Control Agents
Chorionic Gonadotropin
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009