Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)
• Overall Status: Completed
• CT.gov ID: NCT00829075
• Collaborator: (none)
• Location: 1
• Arms: 3
• Duration (Months): 23

Study Details

Study Description

Brief Summary

Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte recipients was compared.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Stimulation	Drug: r-FSH; Drug: HP-hMG; Drug: r-FSH plus HP-hMG	Phase 4

Study Design

• Study Type: Interventional
• Official Title: A Prospective, Randomized, Controlled Trial Comparing Three Different Gonadotrophin Regimens in Oocyte Donors: Ovarian Response and IVF Outcome
• Study Start Date: Jan 1, 2005
• Actual Study Completion Date: Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I only r-FSH TREATMENT	Drug: r-FSH
Experimental: II only HP-hMG TREATMENT	Drug: HP-hMG
Experimental: III r-FSH plus HP-hMG TREATMENT	Drug: r-FSH plus HP-hMG

Outcome Measures

Primary Outcome Measures

1. The aim of this study was to verify whether different gonadotrophin regimes could affect controlled ovarian stimulation (COS) parameters and IVF outcome in an egg donation program. [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 34 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy women 18-34 years of age

• regular menstrual cycles

• no family history of hereditary or chromosomal diseases

• normal karyotype

• BMI 18-29 Kg/m2

• negative screening for sexually transmitted diseases

Exclusion Criteria:

• women with PCOS were not included in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IVI Valencia	Valencia		Spain	46015

Sponsors and Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

• Principal Investigator: Marco Melo, MDPhD, IVI Valencia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00829075
• Other Study ID Numbers: VLC-MM-0501-37
• First Posted: Jan 26, 2009
• Last Update Posted: Jan 26, 2009
• Last Verified: Jan 1, 2009

Study Results

No Results Posted as of Jan 26, 2009