Type of Gonadotropin and Embryo Kinetics of Development

Infertility Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02402192
• Other study ID #: 1411-MAD-079-CB
• Status: Terminated
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2022
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 201
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Corifollitropin alfa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

References & Publications (6)

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 anta — View Citation

García-Velasco JA, Zúñiga A, Pacheco A, Gómez R, Simón C, Remohí J, Pellicer A. Coasting acts through downregulation of VEGF gene expression and protein secretion. Hum Reprod. 2004 Jul;19(7):1530-8. Epub 2004 May 20. — View Citation

Meseguer M, Herrero J, Tejera A, Hilligsøe KM, Ramsing NB, Remohí 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. — View 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. — View Citation

Requena A, Cruz M, Collado D, Izquierdo A, Ballesteros A, Muñoz M, García-Velasco JA. Evaluation of the degree of satisfaction in oocyte donors using sustained-release FSH corifollitropin a. Reprod Biomed Online. 2013 Mar;26(3):253-9. doi: 10.1016/j.rbmo. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T5 defined as the time that embryo needs to reach a 5-cell stage.		Baseline
Secondary	Length of stimulation (days)		a month
Secondary	Total dose of gonadotropins (IU)		A month
Secondary	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		A month
Secondary	Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation		A month
Secondary	Levels of progesterone (ng/ml)		A month
Secondary	Fertilization rate		A month
Secondary	Number of embryos transferred and cryopreserved		A month
Secondary	Pregnancy rate		A month
Secondary	Implantation rate		A monthe
Secondary	Miscarriage rate		A month
Secondary	Cancellation rate per cycle initiated		A month
Secondary	Ovarian hyperstimulation syndrome rate		A month
Secondary	Timings of cellular divisions		A month