Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

October 24, 2014 updated by: Institut Universitari Dexeus
The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . This study will be performed in egg recipients and donors but this type of treatment is meant to be implemented in fertility preservation patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08037
        • Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • premenopausal women, 18-35 years old, FSH levels < 10 mIU/ml; AFC> 10
  • regular cycles
  • BMI < 28
  • signed informed consent

Recipients:

  • Infertile women eligible for oocytes donation
  • BMI < 35
  • Signed informed consent form

Exclusion Criteria:

-Polycystic ovarian syndrome, gonadotropins allergy

Recipients:

  • Women eligible for oocytes donation
  • BMI >35
  • Uncontrolled Endocrine Pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lutheal phase ovarian stimulation
Early luteal phase Controlled ovarian hyperstimulation: we will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix to induce luteolysis and FSHr (dose according to BMI and AFC )IU/day for controlled ovarian hyperstimulation until achieving criteria for hCG , to induce final oocyte maturation. Mature oocytes will be vitrified. After warming, oocytes will be inseminated by ICSI with the recipients partners semen sample . Recipient endometrium will be primed with estrogen and progesterone , and embryo transfer will be performed on the 3rd day 3 of embryo cleavage.
Drug: gonadotropins plus GnRH antagonists
Other Names:
  • Ovarian stimulation
Drug: ganirelix
Other Names:
  • the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: six weeks after transfer procedure
six weeks after transfer procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Mature oocytes
Time Frame: Day of oocyte retrieval
Day of oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Collaborators

FUNDACION DEXEUS SALUT DE LA DONA
Ayudas Merck Serono de Investigación 2012

Investigators

  • Principal Investigator: Francisca Martínez, PhD, Fundación Dexeus Salut de la Dona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 24, 2014

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEX005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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