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

NCT01385332 | Completed

• 1 other identifier: UREP-ONCO-2010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stimulation in the Ovary

Keywords

Metaphase II; Ovarian stimulation; Egg donors

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Early luteal phase -COH-

ACTIVE COMPARATOR

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

Late folicular phase - COH -

ACTIVE COMPARATOR

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-

Interventions

Early luteal phase PROCEDURE

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.

Early luteal phase -COH-

Late follicular phase -COH- PROCEDURE

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.

Late folicular phase - COH -

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• premenopausal women 18-30 years old, with FSH levels \< 10mIU
• irregular menstrual cycle
• BMI between 12-28
• signed inform consent

You may not qualify if:

• Polycystic ovarian syndrome, gonadotropins allergy

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Servei de Ginecologia i Obstetricia, Hospital del Mar-Parc Salut Mar

Barcelona, 08003, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 30, 2011
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

ES (1)