Clinical trial NCT02402192: Type of Gonadotropin and Embryo Kinetics of Development
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: corifollitropin alfa
recombinant FSH
HP-hMG
time-lapse
kinetics of development
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: T5 defined as the time that embryo needs to reach a 5-cell stage.
timeFrame: Baseline
Secondary outcomes:
measure: Length of stimulation (days)
timeFrame: a month
measure: Total dose of gonadotropins (IU)
timeFrame: A month
measure: 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
timeFrame: A month
measure: Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
timeFrame: A month
measure: Levels of progesterone (ng/ml)
timeFrame: A month
measure: Fertilization rate
timeFrame: A month
measure: Number of embryos transferred and cryopreserved
timeFrame: A month
measure: Pregnancy rate
timeFrame: A month
measure: Implantation rate
timeFrame: A monthe
measure: Miscarriage rate
timeFrame: A month
measure: Cancellation rate per cycle initiated
timeFrame: A month
measure: Ovarian hyperstimulation syndrome rate
timeFrame: A month
measure: Timings of cellular divisions
timeFrame: A month
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.