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

NCT02412904 | Completed Phase 4

• 1 other identifier: 130120
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES)

  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.

  3 to 5 days after the ovarian punction

Secondary Outcomes (4)

• 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

Study Arms (2)

drug to ovulation induction: rFSH

OTHER

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

Drug: rFSH

drug to ovulation induction :HMG

OTHER

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

Drug: HMG

Interventions

rFSH 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

Also known as: Puregon®, Organon Ltd., Irlanda

drug to ovulation induction: rFSH

HMG 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

Also known as: Menopur

drug to ovulation induction :HMG

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Center for Human Reproduction: collaborator

Study Sites (1)

Centro de Reproduçao Humana Insemine

Porto Alegre, RGS, 90001003, Brazil

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin beta; Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• João SL Cunha Filho, Dr

  Centro de Reproduçao Humana Insemine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: April 9, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

BR (1)