Single Human Embryo Transfer in Assisted Reproduction Programs (SET)

Fundacion Para La Investigacion Hospital La Fe

Status and phase: Unknown; Early Phase 1

Conditions: Multiple Pregnancies

Treatments: Other: Single embryo transfer in women at risk of multiple pregnancies

Study type: Interventional

Funder types: Other

Identifiers

NCT01471951

2011/0329

Details and patient eligibility

About

Embryo selection based on the use of morphometric parameters should increase the implantation success rate.

One of the most important issues of "Assisted Reproduction Technologies (ART)" is the possibility of multiple pregnancies which carries a significant risk for maternal-fetal health. These risks can be reduced by restricting the number of embryos transferred.

To do this, it is essential to improve current techniques of embryo selection by developing new tools that would allow the selection of the embryos with higher implantation potential. In previous works (Molina et al 2011) the investigators have demonstrated greater efficacy for the embryo classification systems based on the use of the morphometric variables. The investigators have also developed a profile of embryo implantation using these morphometric variables. In this project the investigators intend to validate the clinical validity of this new embryo classification system by conducting a prospective study of single embryo transfer (SET) in young women at risk of multiple pregnancies.

Enrollment: 154 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Personal and family history without interest, not toxic habits.
• Less than 35 years at the time of IVF-ICSI cycle
• Sterility of unknown origin or tubal obstruction.

Exclusion criteria

• Repeat nonvoluntary abortions
• Endometriosis
• Polycystic ovary syndrome (criteria Rotterdam 2004)
• Severe male factor (REM <1 million sperm / ml)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

single embryo transfer

Experimental group

Treatment:

Other: Single embryo transfer in women at risk of multiple pregnancies