NCT01946022

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

August 2, 2013

Last Update Submit

November 6, 2013

Conditions

InfertilityIn Vitro Fertilization Protocols

Keywords

infertilityovulation inductionluteal phasegranulosa cells functionGnRH agonist and antagonistHMGFSHr

Outcome Measures

Primary Outcomes (2)

  • 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

    after 48h in media culture

  • Number of retrieved oocytes

    Immediately after the ovarian punction the number of retrieved oocytes will be evaluated

    After the ovarian punction

Secondary Outcomes (2)

  • number of embryos

    3 to 5 days after ovarian punction

  • Subgroup analyses comparing FSH versus HMG protocols

    after ovarian punction

Study Arms (2)

GnRH Agonist

ACTIVE COMPARATOR

GnRH long agonist protocol of invitro fertilization

Drug: randomization between the two GnRH analogues (agonist and antagonist)

GnRH Antagonist

ACTIVE COMPARATOR

GnRH fixed antagonist protocol of in vitro fertilization

Drug: randomization between the two GnRH analogues (agonist and antagonist)

Interventions

randomization between the two GnRH analogues (agonist and antagonist)DRUG
GnRH AgonistGnRH Antagonist

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Projeto Cegonha

Porto Alegre, Rio Grande do Sul, 90020160, Brazil

RECRUITING

Insemine

Porto Alegre, Rio Grande do Sul, 91330001, Brazil

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Rita d Chapon

CONTACT

5192028288rchapon@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

September 19, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2014

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

BR(2)