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Type of Gonadotropin and Embryo Kinetics of Development (PEM-ESD)

Primary Purpose

Infertility

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Corifollitropin alfa
Sponsored by
IVI Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring corifollitropin alfa, recombinant FSH, HP-hMG, time-lapse, kinetics of development

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women <38 years old
  • Weight <60 kg
  • Own oocytes
  • Patients have to provide signed informed consent

Exclusion Criteria:

  • Oocyte donors
  • Vitrified oocytes
  • Severe male factor (<1 million spz/ml)
  • Weight >60 kg

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Corifollitropin alfa

    recombinant FSH

    HP- hMG

    Arm Description

    Under current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®). From day 6 stimulation and even prior to induction of ovulation day, 0.25 mg / day was administered sc ganirelix (Orgalutran®). From day 8 stimulation and depending on the ovarian response, you can add recombinant FSH (Puregon) up to 150 IU by Puregon Pen® device. In the presence of 3 or more follicles ≥17 mm, ovulation is induced with a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) if there is no risk of OHSS, and 36 hours later he held the follicular puncture oocyte retrieval.

    Under current practice, 67 participants will be stimulated with a daily dose of recombinant FSH. Administration of recombinant FSH (Puregon) starts at an initial dose of 150-225 IU / day by the Puregon Pen® device. From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of recombinant FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg or Decapeptyl hCG 6500u (Ovitrelle) is given if there is no risk of OHSS, and 36 hours then held follicular puncture for recovering oocytes.

    Under current practice, 67 participants will be stimulated with HP-hMG, following the same pattern described for the group of recombinant FSH. In this case, the initial dose is 225-300 IU / day of HP-hMG (Menopur®). From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of HP-hMG according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) is given if there is no risk of OHSS and 36 hours then held the follicular puncture for oocyte retrieval .

    Outcomes

    Primary Outcome Measures

    T5 defined as the time that embryo needs to reach a 5-cell stage.

    Secondary Outcome Measures

    Length of stimulation (days)
    Total dose of gonadotropins (IU)
    Levels of FSH (IU) Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
    Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
    Levels of progesterone (ng/ml)
    Fertilization rate
    Number of embryos transferred and cryopreserved
    Pregnancy rate
    Implantation rate
    Miscarriage rate
    Cancellation rate per cycle initiated
    Ovarian hyperstimulation syndrome rate
    Timings of cellular divisions

    Full Information

    First Posted
    March 18, 2015
    Last Updated
    August 9, 2022
    Sponsor
    IVI Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02402192
    Brief Title
    Type of Gonadotropin and Embryo Kinetics of Development
    Acronym
    PEM-ESD
    Official Title
    A Prospective Randomized Trial to Analyze the Effect of the Gonadotropin Administered During Control Ovarian Stimulation on Embryo Kinetics of Development
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IVI Madrid

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    corifollitropin alfa, recombinant FSH, HP-hMG, time-lapse, kinetics of development

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    201 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Corifollitropin alfa
    Arm Type
    Active Comparator
    Arm Description
    Under current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®). From day 6 stimulation and even prior to induction of ovulation day, 0.25 mg / day was administered sc ganirelix (Orgalutran®). From day 8 stimulation and depending on the ovarian response, you can add recombinant FSH (Puregon) up to 150 IU by Puregon Pen® device. In the presence of 3 or more follicles ≥17 mm, ovulation is induced with a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) if there is no risk of OHSS, and 36 hours later he held the follicular puncture oocyte retrieval.
    Arm Title
    recombinant FSH
    Arm Type
    Active Comparator
    Arm Description
    Under current practice, 67 participants will be stimulated with a daily dose of recombinant FSH. Administration of recombinant FSH (Puregon) starts at an initial dose of 150-225 IU / day by the Puregon Pen® device. From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of recombinant FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg or Decapeptyl hCG 6500u (Ovitrelle) is given if there is no risk of OHSS, and 36 hours then held follicular puncture for recovering oocytes.
    Arm Title
    HP- hMG
    Arm Type
    Active Comparator
    Arm Description
    Under current practice, 67 participants will be stimulated with HP-hMG, following the same pattern described for the group of recombinant FSH. In this case, the initial dose is 225-300 IU / day of HP-hMG (Menopur®). From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of HP-hMG according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) is given if there is no risk of OHSS and 36 hours then held the follicular puncture for oocyte retrieval .
    Intervention Type
    Drug
    Intervention Name(s)
    Corifollitropin alfa
    Other Intervention Name(s)
    Elonva
    Primary Outcome Measure Information:
    Title
    T5 defined as the time that embryo needs to reach a 5-cell stage.
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Length of stimulation (days)
    Time Frame
    a month
    Title
    Total dose of gonadotropins (IU)
    Time Frame
    A month
    Title
    Levels of FSH (IU) Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
    Time Frame
    A month
    Title
    Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
    Time Frame
    A month
    Title
    Levels of progesterone (ng/ml)
    Time Frame
    A month
    Title
    Fertilization rate
    Time Frame
    A month
    Title
    Number of embryos transferred and cryopreserved
    Time Frame
    A month
    Title
    Pregnancy rate
    Time Frame
    A month
    Title
    Implantation rate
    Time Frame
    A monthe
    Title
    Miscarriage rate
    Time Frame
    A month
    Title
    Cancellation rate per cycle initiated
    Time Frame
    A month
    Title
    Ovarian hyperstimulation syndrome rate
    Time Frame
    A month
    Title
    Timings of cellular divisions
    Time Frame
    A month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    37 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women <38 years old Weight <60 kg Own oocytes Patients have to provide signed informed consent Exclusion Criteria: Oocyte donors Vitrified oocytes Severe male factor (<1 million spz/ml) Weight >60 kg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22975113
    Citation
    Meseguer M, Rubio I, Cruz M, Basile N, Marcos J, Requena A. Embryo incubation and selection in a time-lapse monitoring system improves pregnancy outcome compared with a standard incubator: a retrospective cohort study. Fertil Steril. 2012 Dec;98(6):1481-9.e10. doi: 10.1016/j.fertnstert.2012.08.016. Epub 2012 Sep 10.
    Results Reference
    background
    PubMed Identifier
    19684043
    Citation
    Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators. A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2009 Dec;24(12):3063-72. doi: 10.1093/humrep/dep291. Epub 2009 Aug 14. Erratum In: Hum Reprod. 2014 May;29(5):1116-20.
    Results Reference
    result
    PubMed Identifier
    15155606
    Citation
    Garcia-Velasco JA, Zuniga A, Pacheco A, Gomez R, Simon C, Remohi J, Pellicer A. Coasting acts through downregulation of VEGF gene expression and protein secretion. Hum Reprod. 2004 Jul;19(7):1530-8. doi: 10.1093/humrep/deh298. Epub 2004 May 20.
    Results Reference
    result
    PubMed Identifier
    23352098
    Citation
    Requena A, Cruz M, Collado D, Izquierdo A, Ballesteros A, Munoz M, Garcia-Velasco JA. Evaluation of the degree of satisfaction in oocyte donors using sustained-release FSH corifollitropin alpha. Reprod Biomed Online. 2013 Mar;26(3):253-9. doi: 10.1016/j.rbmo.2012.11.015. Epub 2012 Dec 5.
    Results Reference
    result
    PubMed Identifier
    21892335
    Citation
    Seyhan A, Ata B. The role of corifollitropin alfa in controlled ovarian stimulation for IVF in combination with GnRH antagonist. Int J Womens Health. 2011;3:243-55. doi: 10.2147/IJWH.S15002. Epub 2011 Aug 8.
    Results Reference
    result
    PubMed Identifier
    21828117
    Citation
    Meseguer M, Herrero J, Tejera A, Hilligsoe KM, Ramsing NB, Remohi J. The use of morphokinetics as a predictor of embryo implantation. Hum Reprod. 2011 Oct;26(10):2658-71. doi: 10.1093/humrep/der256. Epub 2011 Aug 9.
    Results Reference
    result

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    Type of Gonadotropin and Embryo Kinetics of Development

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