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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN56275481 |
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Date of registration:
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04/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of human fresh vs aseptically vitrified oocytes
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Scientific title:
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Fresh vs aseptically vitrified oocytes: A prospective observational cohort study |
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Date of first enrolment:
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19/01/2014 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN56275481 |
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Study type:
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Observational |
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Study design:
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Prospective observational cohort study (Other)
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Achilleas
Papatheodorou |
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Address:
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Iakentro Advanced Medical Center
Ag. Vasileiou 4
Harilaou
54250
Thessaloniki
Greece |
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Telephone:
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Oocyte donation
Pregnancy and Childbirth
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Intervention(s)
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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 cryoprotectans before they are loaded in carriers which are inserted in a protective straw which will be thermo-sealed and then plunged in liquid nitrogen. After a short period of time (1-3 months, depending the case) the oocytes are warmed and used in the patients. Intracytoplasmic sperm injection is performed to these oocytes in order to be fertilized. The resulting embryos are cultured until day 5 of their development. Some embryos are transferred to the recipients and the remaining are cryopreserved. Clinical results are monitored in each case, until the birth of the children (9 months after the embryo transfer).
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Secondary ID(s)
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IRB 1/14 & 808a/8-3-2011
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Source(s) of Monetary Support
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Iakentro Advanced Medical Center
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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