Evaluation of Granulosa Cells Function After IVF Protocols

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility, In Vitro Fertilization Protocols

Intervention / Treatment
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* Drug: randomization between the two GnRH analogues (agonist and antagonist)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of embryos | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HMG, FSHr, infertility, ovulation induction, luteal phase, granulosa cells function, GnRH agonist and antagonist