A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors

Stimulation in the Ovary Clinical Trial

Official title:

A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385332
• Other study ID #: UREP-ONCO-2010
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: September 19, 2017
• Start date: March 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2017
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of two new patterns of controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study will be performed in egg donors but these new patterns will be implemented in fertility preservation patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• premenopausal women 18-30 years old, with FSH levels < 10mIU

• irregular menstrual cycle

• BMI between 12-28

• signed inform consent

Exclusion Criteria:

• Polycystic ovarian syndrome, gonadotropins allergy

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Stimulation in the Ovary

Intervention

Procedure:
• Early luteal phase
We will administer in the tenth day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.
• Late follicular phase -COH-
We will administer in the 20th day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.

Locations

Country	Name	City	State
Spain	Servei de Ginecologia i Obstetricia, Hospital del Mar-Parc Salut Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eggs	The results will be presented in one year, egg recipients will be followed until 12 weeks of pregnancy.	Participants will be followed after 1-3 hrs of follicular aspiration.