Evaluation of Granulosa Cells Function After IVF Protocols

Not Applicable

• Conditions: Infertility; In Vitro Fertilization Protocols
• Interventions: Drug: randomization between the two GnRH analogues (agonist and antagonist)

• Registration Number: NCT01946022
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-02
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-07
• Primary Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH Agonist	randomization between the two GnRH analogues (agonist and antagonist)	GnRH long agonist protocol of invitro fertilization
GnRH Antagonist	randomization between the two GnRH analogues (agonist and antagonist)	GnRH fixed antagonist protocol of in vitro fertilization

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Insemine; 🇧🇷 Porto Alegre, RS, Brazil

Projeto Cegonha; 🇧🇷 Porto Alegre, RS, Brazil