Clinical trial NCT00824629: Embryo Transfer: Direct Versus Afterloading Trial
Official title: Direct Transfer vs Previous Cervical Canalization Transfer ("Afterloading"): Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Embryo transfer
IVF
Ultrasound embryo transfer
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate two types of embryo transfer procedure.

The investigators will compare direct embryo transfer against afterloading embryo transfer.


Eligibility criteria: Inclusion Criteria:

* Patients in IVF/CICSI program
* Transfer day:2 or 3 after ovum pick-up

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 8 weeks after embryo transfer
Secondary outcomes:
measure: Difficulty of embryo transfer
timeFrame: During embryo transfer procedure
measure: Duration of embryo transfer
timeFrame: During embryo transfer procedure
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Study officials:
affiliation: Departamento de Obstetricia, Ginecologia y Reproduccion , Institut Universitari Dexeus
name: Buenaventura Coroleu, PhD., MD.
role: STUDY_DIRECTOR
References:
citation: Coroleu B, Carreras O, Veiga A, Martell A, Martinez F, Belil I, Hereter L, Barri PN. Embryo transfer under ultrasound guidance improves pregnancy rates after in-vitro fertilization. Hum Reprod. 2000 Mar;15(3):616-20. doi: 10.1093/humrep/15.3.616.
citation: Coroleu B, Barri PN, Carreras O, Martinez F, Parriego M, Hereter L, Parera N, Veiga A, Balasch J. The influence of the depth of embryo replacement into the uterine cavity on implantation rates after IVF: a controlled, ultrasound-guided study. Hum Reprod. 2002 Feb;17(2):341-6. doi: 10.1093/humrep/17.2.341.
citation: Coroleu B, Barri PN, Carreras O, Martinez F, Veiga A, Balasch J. The usefulness of ultrasound guidance in frozen-thawed embryo transfer: a prospective randomized clinical trial. Hum Reprod. 2002 Nov;17(11):2885-90. doi: 10.1093/humrep/17.11.2885.
citation: Coroleu B, Barri PN, Carreras O, Belil I, Buxaderas R, Veiga A, Balasch J. Effect of using an echogenic catheter for ultrasound-guided embryo transfer in an IVF programme: a prospective, randomized, controlled study. Hum Reprod. 2006 Jul;21(7):1809-15. doi: 10.1093/humrep/del045. Epub 2006 Mar 23.
citation: Matorras R, Mendoza R, Exposito A, Rodriguez-Escudero FJ. Influence of the time interval between embryo catheter loading and discharging on the success of IVF. Hum Reprod. 2004 Sep;19(9):2027-30. doi: 10.1093/humrep/deh366. Epub 2004 Jun 10.
citation: Neithardt AB, Segars JH, Hennessy S, James AN, McKeeby JL. Embryo afterloading: a refinement in embryo transfer technique that may increase clinical pregnancy. Fertil Steril. 2005 Mar;83(3):710-4. doi: 10.1016/j.fertnstert.2004.08.022.