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NCT Number: NCT02412904

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Centro de Reproduçao Humana Insemine

Porto Alegre, RGS, 90001003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Puregon®, Organon Ltd., Irlanda

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

Other names: Menopur

Primary outcomes

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

    Time frame: 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 outcomes

  1. number of follicles graduated by size in groups of 13-14mm; 15-16mm and more than 17mm

    Time frame: 10 to 13 days after the IVF protocol starts

  2. total number of units of gonadotrophins used to ovarian stimulation

    Time frame: 10 to 13 days after the IVF protocol starts

  3. number of oocytes retrieved (MII)

    Time frame: 10 to 13 days after the IVF protocol starts

  4. number of embryos

    Time frame: 3 to 5 days after the ovarian punction

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Center for Human Reproduction

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2015
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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