CClinicalTrials.gg
Status unknownNCT01946022Updated Nov 7, 2013

Evaluation of Granulosa Cells Function After IVF Protocols

An interventional study of randomization between the two GnRH analogues (agonist and antagonist) in Infertility and In Vitro Fertilization Protocols, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 2 sites in Brazil. Open to female participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-07.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility
  • In Vitro Fertilization Protocols

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Keywords

  • infertility
  • ovulation induction
  • luteal phase
  • granulosa cells function
  • GnRH agonist and antagonist
  • HMG
  • FSHr
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 28 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Patients submitted to intracytoplasmatic sperm injection (ICSI)
  • Ovarian mass or cyst
  • Clinical / endocrine pathologies
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • 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)

Interventions

  • Drugrandomization between the two GnRH analogues (agonist and antagonist)
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: after 48h in media culture

  2. Number of retrieved oocytes

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

    Time frame: After the ovarian punction

Secondary outcomes

  1. number of embryos

    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

  2. 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

    Time frame: after ovarian punction

07

Study locations

2 of 2 sites recruiting
  • Projeto Cegonha
    Porto Alegre, RS 90020160, Brazil
    • Rita d Chapon · Contact · rchapon@gmail.com · 5192028288
    • Rita Chapon · Principal investigator
    Recruiting
  • Insemine
    Porto Alegre, RS 91330001, Brazil
    • Rita · Contact
    • Rita Chapon · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01946022
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Sep 19, 2013
Start date
Sep 2013
Primary completion
Oct 2014 (estimated)
Last update
Nov 7, 2013

Study contacts

Rita d Chapon
Contact
rchapon@gmail.com
5192028288
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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