Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

Infertility Clinical Trial

Official title:

Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00575302
• Other study ID #: Study 300 versus 450
• Status: Withdrawn
• Phase: Phase 4
• First received: December 17, 2007
• Last updated: April 12, 2010
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2010
• Source: Centre Hospitalier Chretien
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.

Description:

Women > 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:

300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.

Patient can be eligible for several cycles in same protocol.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 400
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 38 Years to 42 Years

Eligibility

Inclusion Criteria:

• Women > 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.

• Insufficient response is defined as: development of = 4 mature follicles (of = 16 mm) at time of hCG administration.

• Patient can be eligible for several cycles in same protocol.

Exclusion Criteria:

• Patients who already received doses > 225 IU

• Patients older than 42 years

• Patients with basal FSH concentrations = 15 mU/ml at day 3

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:
• Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 300 U
• Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 450 U

Locations

Country	Name	City	State
Belgium	CHU Saint-Pierre	Brussels
Belgium	IMEC	Brussels
Belgium	UZ Gent	Gent
Belgium	CHC Saint-Vincent	Rocourt	Liège

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Chretien	EMD Serono

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of mature oocytes		1 month	No
Secondary	follicular development		1 month	No
Secondary	fertilization rate		1 month	No
Secondary	implantation rate		1 month	No
Secondary	embryo quality		1 month	No
Secondary	pregnancy rate		1 month	No