Performance Study of New Media for Vitrification of Human Oocytes

About this trial

Last updated 12 years ago

Study ID

Vitrolife-oocyte-vitri 01

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 37 Years

Female

Trial Timing

Ended 14 years ago

What is this trial about?

The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte vitrification/warming media and the vitrification device Rapid-i™, when using vitrification as a cryopreservation method for human oocytes.

What are the participation requirements?

Inclusion Criteria

* Couple agreed to participate in study and has signed the Informed Consent Document before any study-related activities

* Patient age (female): 18-37 years (including oocyte donors)

* BMI 18-27 kg/m2 (female)

* 2 ovaries, normal uterine cavity (female)

* Day 3 FSH ≤ 10mIU, E2 <80 pg/mL and an AFC ≥12 (both ovaries, 3 mm or greater) (female)

* AMH >1 (female)

* Ejaculatory sperm (male)

* ICSI fertilization

* Long standard stimulation protocol

* English speaking

Exclusion Criteria

* Previous participation in the study

* ≥2 previous failed IVF cycles

* Endometrioma

* Presence of a hydrosalpinx

* History of recurrent miscarriage (defined as ≥2 clinical recognized SABs)

* Not willing to have ICSI performed

* Cycle length >6 weeks [a diagnosis of PCOS will not exclude from the study unless typical cycle length is greater than 6 weeks; this criteria would exclude hypothalamic-hypogonadotropic patients]