Clinical trial NCT01481571: Performance Study of New Media for Vitrification of Human Oocytes
Official title: Performance Study of New Media for Vitrification of Human Oocytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Media for vitrification/warming of human oocytes
Lead sponsor: Vitrolife
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A multi-center prospective sibling oocyte vitrification trial where, in the first phase, half of the patients' oocytes will be vitrified and warmed (experimental group). The remaining oocytes will not be vitrified and will serve as the control group. In the second phase all of the patients' oocytes will be vitrified and the embryo transfer will be performed in a following cycle. This simulates the situation of a normal cryopreservation embryo transfer. The study population consists of 20 women who will undergo a fresh IVF cycle during the study period. The primary objective in the first phase is to assess survival, fertilization and embryo development after oocyte vitrification/warming with the new media. The results will be compared with results from sibling oocytes which have not been vitrified. Secondary objectives are to assess the clinical results such as implantation, miscarriage and pregnancy rate as well as delivery rate and neonatal outcome.

The primary objective in the second phase is to assess the delivery rate after oocyte vitrification/warming with the new media. Secondary objectives are to assess survival, fertilization, embryo development, utilization rate, pregnancy rate and neonatal outcome on the previously vitrified and warmed oocytes. The results will be compared with results from a control group of patients, treated at the same clinics within the same time period, using the same inclusion and exclusion criteria. All patients who undergo embryo transfer will have a serum beta-hCG test conducted 14 days after oocyte retrieval. If positive, repeat beta-hCG testing will be conducted 2-4 days later. If appropriate, a pregnancy ultrasound will be conducted between 6-8 weeks gestation (menstrual age) to record gestational sac(s) and fetal heart beat. The delivery outcome will also be recorded. For patients with an unsuccessful treatment, there will be a follow-up period of 6 months after study completion. From this follow-up, data from frozen cycles, i.e. from embryos after oocyte vitrification, can be evaluated as well.

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

Primary outcomes:
measure: Embryo development after oocyte vitrification/warming.
timeFrame: 5 days after oocyte retrieval
Secondary outcomes:
measure: Implantation rate of previously vitrified/warmed oocytes.
timeFrame: 4 weeks after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: 3 months after embryo transfer
measure: Live birth
timeFrame: 9 months after embryo transfer
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The DFW Fertility Associates, Reproductive Endocrinology and Infertility, Dallas Fertility Centre
state: Texas
city: Frisco
country: United States
facility: Frisco IVF
state: Texas
Study officials:
name: Marius Meintjes, Dr
role: PRINCIPAL_INVESTIGATOR
References: