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

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.

Study Overview

• Status: Completed
• Conditions: Stimulation in the Ovary
• Intervention / Treatment: Procedure: Early luteal phase; Procedure: Late follicular phase -COH-

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Servei de Ginecologia i Obstetricia, Hospital del Mar-Parc Salut Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early luteal phase -COH-; We perform an standard antagonist protocol beginning the second day of the menstrual cycle compared with an antagonist protocol beginning in the early luteal phase.	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.
Active Comparator: Late folicular phase - COH -; We perform an standard antagonist protocol beginning the second day of the menstrual cycle compared with an antagonist protocol beginning in the late follicular phase.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Ovarian stimulation; Metaphase II; Egg donors
• Other Study ID Numbers: UREP-ONCO-2010