Clinical trial NCT02412904: Randomized Controlled Trial Comparing Embryonic Quality in rFSH Versus hMG in IVF Protocol With GnRH Antagonist
Official title: Phase 4 Study Comparing Recombinant Follicle Stimulating Hormone (rFSH) or Ultra-pure to HMG in Patients Submitted to IVF Using Gnrh Antagonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: follicular stimulating hormone
human menopausal gonadotrophin
Recombinant follicular stimulating hormone (rFSH)
Gonadotrophin releasing hormone (GnRH) antagonists
GnRH agonist
in vitro fertilization
controled ovarian stimulation
number of mature oocytes
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Center for Human Reproduction
First posted: 2015-04-09
Enrollment: 188
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF. However, there is a debate in the literature which one is better to induce ovulation in patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion.

The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.

Detailed description: To compare embryonic quality and other clinical outcomes when using human menopause gonadotropin (hMG) or recombinant follicle stimulating hormone (rFSH) to the ovarian stimulation in IVF cycles with the GnRH antagonist protocol.

Design: open randomized single center study with infertile patients submitted to IVF comparing IVF outcomes between hMG and rFSH when controlled with GnRH antagonist.

Setting: A single private center of reproductive medicine in association with Universidade Federal do Rio Grande do Sul.

Patients: Infertile women with normal ovarian reserve with IVF indication. Intervention: The patients were randomized in two groups, 85 received rFSH and 83 received hMG to ovulation induction, both groups used GnRH antagonist to prevent ovulation.

Main Outcome Measure: Total embryonic score and best embryonic score. Secondary outcomes: Total dose of gonadotropins, number and size of follicles in the end of the stimulation, number of mature oocytes, number of embryos, pregnancy rates.

Eligibility criteria: Inclusion Criteria:

* 25 to 40 y
* infertile
* submitted to IVF
* no hormonal disease
* normal FSH (\< 10)
* anti-mullerian hormone (AMH) \> 1 ng and \< 10 ng
* both ovaries
* only first or second IVF

Exclusion Criteria:

* thyroid-stimulating hormone (TSH), prolactin (PRL) altered
* endometrioma
* ovarian tumor or cysts
* previous Ovarian Hyperstimulation Syndrome (OHSS)
* severe male factor

Primary outcomes:
measure: Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES)
timeFrame: 3 to 5 days after the ovarian punction
Secondary outcomes:
measure: number of follicles graduated by size in groups of 13-14mm; 15-16mm and more than 17mm
timeFrame: 10 to 13 days after the IVF protocol starts
measure: total number of units of gonadotrophins used to ovarian stimulation
timeFrame: 10 to 13 days after the IVF protocol starts
measure: number of oocytes retrieved (MII)
timeFrame: 10 to 13 days after the IVF protocol starts
measure: number of embryos
timeFrame: 3 to 5 days after the ovarian punction
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Reproduçao Humana Insemine
state: RGS
Study officials:
affiliation: Centro de Reproduçao Humana Insemine
name: João SL Cunha Filho, Dr
role: PRINCIPAL_INVESTIGATOR
References: