Evaluation of Granulosa Cells Function After IVF Protocols

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01946022
• Other study ID #: 13-0120
• Secondary ID: HCPA
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2013
• Last updated: November 6, 2013
• Start date: September 2013

Study information

• Verified date: November 2013
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Rita d Chapon
• Phone: 5192028288
• Email: rchapon[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• In Vitro Fertilization Protocols
• Infertility

Intervention

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

Locations

Country	Name	City	State
Brazil	Insemine	Porto Alegre	RS
Brazil	Projeto Cegonha	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of retrieved oocytes	Immediately after the ovarian punction the number of retrieved oocytes will be evaluated	After the ovarian punction	Yes
Secondary	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	Yes
Secondary	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	No