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

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Completed

CT.gov ID

NCT02412904

Collaborator

Center for Human Reproduction (Other)

188

Enrollment

Location

Arms

Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: rFSH Drug: HMG	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: drug to ovulation induction: rFSH Patients submitted to IVF that will use rFSH (Puregon®, Organon Ltd., Ireland) for ovarian stimulation	Drug: 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 Other Names: Puregon®, Organon Ltd., Irlanda
Other: drug to ovulation induction :HMG Patients submitted to IVF that will use hMG (Menopur®, Ferring Pharmaceuticals, Denmark) for ovarian stimulation	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 Other Names: Menopur

Arm

Intervention/Treatment

Other: drug to ovulation induction: rFSH

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

Drug: 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

Other Names:

Puregon®, Organon Ltd., Irlanda

Other: drug to ovulation induction :HMG

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

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

Other Names:

Menopur

Outcome Measures

Primary Outcome Measures

Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES) [3 to 5 days after the ovarian punction]
The embryo evaluation will be performed on day three after fertilization based on the Graduated Embryo Score (GES). It will be performed three evaluations occurring at 16 - 18 hours, 25 - 27 hours and 64 - 67 hours post insemination, by the same embryologist (DS) The score is composed by the following criteria: nucleolar alignment along pronuclear axis, regular cleavage and degree of fragmentation at the first cell division, and cell number and morphology on day 3 after fertilization. The score ranges from 20 to 100 per embryo.

Secondary Outcome Measures

number of follicles graduated by size in groups of 13-14mm; 15-16mm and more than 17mm [10 to 13 days after the IVF protocol starts]
total number of units of gonadotrophins used to ovarian stimulation [10 to 13 days after the IVF protocol starts]
number of oocytes retrieved (MII) [10 to 13 days after the IVF protocol starts]
number of embryos [3 to 5 days after the ovarian punction]