Evaluation of Granulosa Cells Function After IVF Protocols

November 6, 2013 updated by: Hospital de Clinicas de Porto Alegre

In Vitro Evaluation of Luteinized Granulosa Cells After Being Submitted to in Vitro Fertilization Protocols With Gonadotropin-Releasing Hormone (GnRH) Agonist and GnRH Antagonist

This study is intended to evaluate ovarian cells after being submitted do different in vitro fertilization protocols. The investigators will analyze hormones secretion and intracellular mechanisms of these cells comparing the GnRH agonist protocol and the GnRH antagonist protocol.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

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

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 91330001
        • Recruiting
        • Insemine
        • Principal Investigator:
          • Rita Chapon
        • Contact:
          • Rita
      • Porto Alegre, RS, Brazil, 90020160
        • Recruiting
        • Projeto Cegonha
        • Contact:
        • Principal Investigator:
          • Rita Chapon

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

20 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient age limit: 39 years
  • Follicle Stimulating Hormone (FSH) < 10 micrometer (mU) / Liter
  • Antral follicular count > 12
  • Regular menses (25 to 35 days)
  • More than 3 oocytes after ovarian punction
  • Anti Mullerian between 1 e 3 ng/ml

Exclusion Criteria:

  • Patients submitted to intracytoplasmatic sperm injection (ICSI)
  • Ovarian mass or cyst
  • Clinical / endocrine pathologies

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GnRH Agonist
GnRH long agonist protocol of invitro fertilization
Drug: randomization between the two GnRH analogues (agonist and antagonist)
Active Comparator: GnRH Antagonist
GnRH fixed antagonist protocol of in vitro fertilization
Drug: randomization between the two GnRH analogues (agonist and antagonist)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of steroid secretion and enzyme expression in in vitro luteinized granulosa cells
Time Frame: after 48h in media culture
evaluation of granulosa cells hormone secretion and enzyme expression in media culture 48 hours after ovarian punction
after 48h in media culture
Number of retrieved oocytes
Time Frame: After the ovarian punction
Immediately after the ovarian punction the number of retrieved oocytes will be evaluated
After the ovarian punction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of embryos
Time Frame: 3 to 5 days after ovarian punction
the embryologist will verify the number of embryos after 3 to 5 days from the ovarian punction
3 to 5 days after ovarian punction
Subgroup analyses comparing FSH versus HMG protocols
Time Frame: after ovarian punction
It will be verified the differences between the two types of gonadotrophins in ovarian stimulation regarding: units of gonadotrophins used, number of retrieved oocytes,number of embryos and embryo score
after ovarian punction

Collaborators and Investigators

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

Sponsor

Hospital de Clinicas de Porto Alegre

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

September 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

November 7, 2013

Last Update Submitted That Met QC Criteria

November 6, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0120
  • HCPA (Other Identifier: Hospital de Clínicas de Porto Alegre)

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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