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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01385332
First received: May 28, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Stimulation in the Ovary
Procedure: Early luteal phase
Procedure: Late follicular phase -COH-

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors

Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Number of eggs [ Time Frame: Participants will be followed after 1-3 hrs of follicular aspiration. ] [ Designated as safety issue: Yes ]
    The results will be presented in one year, egg recipients will be followed until 12 weeks of pregnancy.


Enrollment: 10
Study Start Date: March 2010
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385332

Locations
Spain
Servei de Ginecologia i Obstetricia, Hospital del Mar-Parc Salut Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01385332     History of Changes
Other Study ID Numbers: UREP-ONCO-2010
Study First Received: May 28, 2010
Last Updated: February 13, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Parc de Salut Mar:
Metaphase II
Ovarian stimulation
Egg donors

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases

ClinicalTrials.gov processed this record on November 24, 2014