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

NCT ID: NCT02412904

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

drug to ovulation induction: rFSH

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

Group Type: OTHER

rFSH

Intervention Type: DRUG

the patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and antral follicle count (AFC). This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days

drug to ovulation induction :HMG

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

Group Type: OTHER

HMG

Intervention Type: DRUG

the patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and AFC. This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days

Interventions

rFSH

the patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and antral follicle count (AFC). This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days

Intervention Type: DRUG

HMG

the patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and AFC. This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days

Intervention Type: DRUG

Other Intervention Names

Puregon®, Organon Ltd., Irlanda; Menopur

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Human Reproduction

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

João SL Cunha Filho, Dr

Role: PRINCIPAL_INVESTIGATOR

Centro de Reproduçao Humana Insemine

Locations

Centro de Reproduçao Humana Insemine

Porto Alegre, RGS, Brazil

Countries

Brazil

Other Identifiers

130120

Identifier Type: -

Identifier Source: org_study_id