Randomized Controlled Trial Comparing Embryonic Quality in rFSH Versus hMG in IVF Protocol With GnRH Antagonist

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: HMG; Drug: rFSH

Study type: Interventional

Funder types: Other

Identifiers

NCT02412904

130120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

drug to ovulation induction: rFSH

Other group

Description:

Patients submitted to IVF that will use rFSH (Puregon®, Organon Ltd., Ireland) for ovarian stimulation

Treatment:

Drug: rFSH

drug to ovulation induction :HMG

Other group

Description:

Patients submitted to IVF that will use hMG (Menopur®, Ferring Pharmaceuticals, Denmark) for ovarian stimulation

Treatment:

Drug: HMG