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Evaluation of Granulosa Cells Function After IVF Protocols

Primary Purpose

Infertility, In Vitro Fertilization Protocols

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
randomization between the two GnRH analogues (agonist and antagonist)
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infertility focused on measuring infertility, ovulation induction, luteal phase, granulosa cells function, GnRH agonist and antagonist, HMG, FSHr

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Projeto CegonhaRecruiting
  • InsemineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GnRH Agonist

GnRH Antagonist

Arm Description

GnRH long agonist protocol of invitro fertilization

GnRH fixed antagonist protocol of in vitro fertilization

Outcomes

Primary Outcome Measures

Evaluation of steroid secretion and enzyme expression in in vitro luteinized granulosa cells
evaluation of granulosa cells hormone secretion and enzyme expression in media culture 48 hours after ovarian punction
Number of retrieved oocytes
Immediately after the ovarian punction the number of retrieved oocytes will be evaluated

Secondary Outcome Measures

number of embryos
the embryologist will verify the number of embryos after 3 to 5 days from the ovarian punction
Subgroup analyses comparing FSH versus HMG protocols
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

Full Information

First Posted
August 2, 2013
Last Updated
November 6, 2013
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01946022
Brief Title
Evaluation of Granulosa Cells Function After IVF Protocols
Official Title
In Vitro Evaluation of Luteinized Granulosa Cells After Being Submitted to in Vitro Fertilization Protocols With Gonadotropin-Releasing Hormone (GnRH) Agonist and GnRH Antagonist
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, In Vitro Fertilization Protocols
Keywords
infertility, ovulation induction, luteal phase, granulosa cells function, GnRH agonist and antagonist, HMG, FSHr

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRH Agonist
Arm Type
Active Comparator
Arm Description
GnRH long agonist protocol of invitro fertilization
Arm Title
GnRH Antagonist
Arm Type
Active Comparator
Arm Description
GnRH fixed antagonist protocol of in vitro fertilization
Intervention Type
Drug
Intervention Name(s)
randomization between the two GnRH analogues (agonist and antagonist)
Primary Outcome Measure Information:
Title
Evaluation of steroid secretion and enzyme expression in in vitro luteinized granulosa cells
Description
evaluation of granulosa cells hormone secretion and enzyme expression in media culture 48 hours after ovarian punction
Time Frame
after 48h in media culture
Title
Number of retrieved oocytes
Description
Immediately after the ovarian punction the number of retrieved oocytes will be evaluated
Time Frame
After the ovarian punction
Secondary Outcome Measure Information:
Title
number of embryos
Description
the embryologist will verify the number of embryos after 3 to 5 days from the ovarian punction
Time Frame
3 to 5 days after ovarian punction
Title
Subgroup analyses comparing FSH versus HMG protocols
Description
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
Time Frame
after ovarian punction

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita d Chapon
Phone
5192028288
Email
rchapon@gmail.com
Facility Information:
Facility Name
Projeto Cegonha
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020160
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita d Chapon
Phone
5192028288
Email
rchapon@gmail.com
First Name & Middle Initial & Last Name & Degree
Rita Chapon
Facility Name
Insemine
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91330001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita
First Name & Middle Initial & Last Name & Degree
Rita Chapon

12. IPD Sharing Statement

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Evaluation of Granulosa Cells Function After IVF Protocols

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