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Comparison of human fresh vs aseptically vitrified oocytes

Fresh vs aseptically vitrified oocytes: A prospective observational cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN56275481
Enrollment
90
Registered
2015-11-04
Start date
2014-01-19
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oocyte donation Pregnancy and Childbirth

Interventions

The cryopreservation technique used is vitrification and more specifically the closed vitrification system, in order to achieve aseptically conditions. The human oocytes are exposed in solutions with

Sponsors

Iakentro Advanced Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Oocyte donor inclusion criteria: 1. Up to 32 years old 2. Body mass index of less than 30 kg/m2 3. Regular menstrual cycles of 25–35 days 4. Two normal ovaries based on transvaginal scan findings 5. No polycystic ovary syndrome 6. No known endometriosis 7. No gynecological or medical disorders 8. Agreed to donate their oocytes for treatment anonymously and altruistically 9. Known fertility and good ovarian response 10. Blood sample was collected for karyotype and screening for previous viral infection (hepatitis B and C, human immunodeficiency virus, syphilis) thalassemia and cystic fibrosis 11. A single stimulation cycle was included for each donor Recipient inclusion criteria: 1. Up to 50 years old 2. No history of endometriosis 3. First oocyte donation cycle 4. The recipients and their partners underwent blood screening similar to the donors, hysterosalpingogram and a diagnostic hysteroscopy had eliminated cases presenting hydrosalpinx or intrauterine pathology 5. The recipients had a mock transfer in a cycle previous to their donation cycle and if difficulty was encountered a cervical dilatation was performed 6. The recipient’s partner had no severe male infertility indication

Exclusion criteria

Exclusion criteria: Donor exclusion citeria: Less than 15 retrieved mature oocytes Recipient exclusion criteria: 1. More than 2 previous failed oocyte donation cycles 2. Severe male factor infertility in partner

Design outcomes

Primary

MeasureTime frame
1. Pregnancy rate per cycle, confirmed by the rise of serum b-HCG concentrations, 14 days after embryo transfer 2. Clinical pregnancy rate per cycle, defined by the appearance of a gestational sac and a fetal heartbeat at 8–10 weeks of gestation 3. Ongoing pregnancy rate per cycle, considered the number of pregnancies with fetuses displaying heart activity beyond 12 weeks of gestation per cycle

Secondary

MeasureTime frame
1. Oocyte survival rate, defined as the number of oocytes that survived out of the total number of oocytes warmed, is evaluated 2 hours after the warming of the oocytes 2. Fertilization rate, defined as the number of fertilized oocytes out of the number of oocytes survived, evaluated 16-20 hours after the injection of a spermatozoon to the oocytes 3. Cleavage and top cleavage rate, was defined as the number of cleavage embryos, top quality cleavage embryos respectively out of the total number of fertilized oocytes, evaluated 3 days after the injection of a spermatozoon to the oocytes 4. Blastocyst and the top blastocyst rate, defined as the number of blastocysts and top quality blastocysts respectively out of the total number of fertilized oocytes, evaluated 5 days after the injection of a spermatozoon to the oocytes

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026