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

Phase 4 Study Comparing Recombinant Follicle Stimulating Hormone (rFSH) or Ultra-pure to HMG in Patients Submitted to IVF Using Gnrh Antagonist

Sponsors

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Collaborator: Center for Human Reproduction

Source Hospital de Clinicas de Porto Alegre
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.

Overall Status Completed
Start Date 2014-01-01
Completion Date 2014-12-01
Primary Completion Date 2014-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES) 3 to 5 days after the ovarian punction
Secondary Outcome
Measure Time Frame
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
Enrollment 188
Condition
Intervention

Intervention Type: Drug

Intervention Name: rFSH

Description: 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

Arm Group Label: drug to ovulation induction: rFSH

Other Name: Puregon®, Organon Ltd., Irlanda

Intervention Type: Drug

Intervention Name: HMG

Description: 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

Arm Group Label: drug to ovulation induction :HMG

Other Name: 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

Gender:

Female

Minimum Age:

25 Years

Maximum Age:

40 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
João SL Cunha Filho, Dr Principal Investigator Centro de Reproduçao Humana Insemine
Location
Facility: Centro de Reproduçao Humana Insemine
Location Countries

Brazil

Verification Date

2015-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: drug to ovulation induction: rFSH

Type: Other

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

Label: drug to ovulation induction :HMG

Type: Other

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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