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TerminatedNCT02402192PEM-ESDUpdated Aug 11, 2022

Type of Gonadotropin and Embryo Kinetics of Development

A Phase 4 interventional study of Corifollitropin alfa in Infertility, sponsored by IVI Madrid. Terminated. Open to female participants aged 18 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.

Sponsored by IVI Madrid · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
18 Years to 37 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility

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Keywords

  • corifollitropin alfa
  • recombinant FSH
  • HP-hMG
  • time-lapse
  • kinetics of development
03

Who can participate

Ages eligible
18 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Oocyte donors
  • Vitrified oocytes
  • Severe male factor (\<1 million spz/ml)
  • Weight >60 kg
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
201 participants (actual)

Study arms

  • Active comparator
    Corifollitropin alfa

    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.

    Drug: Corifollitropin alfa

  • Active comparator
    recombinant FSH

    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.

    Drug: Corifollitropin alfa

  • Active comparator
    HP- hMG

    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 .

    Drug: Corifollitropin alfa

Interventions

  • DrugCorifollitropin alfa

    Also known as: Elonva

05

What researchers measure

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

  1. Length of stimulation (days)

    Time frame: a month

  2. Total dose of gonadotropins (IU)

    Time frame: A month

  3. 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

  4. Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation

    Time frame: A month

  5. Levels of progesterone (ng/ml)

    Time frame: A month

  6. Fertilization rate

    Time frame: A month

  7. Number of embryos transferred and cryopreserved

    Time frame: A month

  8. Pregnancy rate

    Time frame: A month

  9. Implantation rate

    Time frame: A monthe

  10. Miscarriage rate

    Time frame: A month

  11. Cancellation rate per cycle initiated

    Time frame: A month

  12. Ovarian hyperstimulation syndrome rate

    Time frame: A month

  13. Timings of cellular divisions

    Time frame: A month

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 22975113 ↗
  • 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. PubMed 19684043 ↗
  • 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. PubMed 15155606 ↗
  • 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. PubMed 23352098 ↗
  • 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. PubMed 21892335 ↗
  • 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. PubMed 21828117 ↗
08

Registry details

Key details

Study ID
NCT02402192
Lead sponsor
IVI Madrid
Responsible party
Juan A Garcia-Velasco (PhD MD, IVI Madrid) — Principal investigator
First posted
Mar 30, 2015
Start date
Apr 2015
Primary completion
Sep 2015
Completion
Dec 2016
Last update
Aug 11, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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