- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01287273
The Impact of Early Embryos Incubation on Pregnancy Rate in IVF (IVF-2010)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
It has been common practice to cryopreserve surplus embryos achieved during IVF treatment or in other situation that embryos are to be preserved for other situations such as suspected ovarian hyper stimulation syndrome, fertility preservation or patient request.
Embryos are usually frozen on day 2, 3 or day 5-6 at the Blastocyst stage. At the time that thawing is planned, patients' cycle is synchronized and prepared either with hormonal treatment or at the natural cycle.
Not all embryos will always survive the thawing and sometimes they will all degenerate.
Embryos that survive the thawing procedure are assessed and replaced on the day of the thaw or left overnight for better selection and will be replaced only if they continue to divide in vitro.
The advantage of embryo transfer on the day of thaw is that embryo exposure in culture is shortened and embryo selection will be occurring in the womb. On the other hand, overnight incubation may avoid transferring embryos that potentially are not able to divide and are biologically not viable.
Although both attitudes are practiced in different IVF centers, at present there are no prospective randomized studies that have been conducted to advise which intervention is better in terms of pregnancy rates.
The purpose of the present study is to assess which technique will result in better pregnancy rates.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
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Haifa, Israel, 34362
- Rekrytering
- Carmel Medical Center
-
Kontakt:
- Martha Dirnfeld, MD
- Telefonnummer: 9724 8250335
- E-post: dirnfeld_martha@clalit.org.il
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Kontakt:
- Shirly Lahav-Baratz, D.Sc
- Telefonnummer: 9724 8250118
- E-post: lahav_shirly@clalit.org.il
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Huvudutredare:
- Martha Dirnfeld, MD
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
660 IVF patients. patients who are candidates for embryo cryopreservation cycle will be offered to participate in the present prospective randomized study.
After detailed verbal and written explanation on the study protocol they will sign an informed consent and then randomized to 2 groups.
Beskrivning
Inclusion Criteria:
- IVF patient who have thawed embryo transfer and can read understand and sigh on informed consent
Exclusion Criteria:
- IVF patient who have thawed embryo transfer and can not read understand and sigh on informed consent/ also those whos embryos will not survive freezing- thawing
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Group A
Transfer at the day of embryo thawing
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Group B
Transfer of thawed embryos 24-72 hours post thawing
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pregnancy as measured by blood test for beta hCG
Tidsram: 12 days following embryos transfer
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as the usual routine, the women come on day 12 or 13 following embryo transfer to pur IVF unit to get blood teat for beta hCG.
When the result show that the beta hCG is above 5 unit/liter we consider it as positive result and the patients is invited for additional blood test 2 days later/
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12 days following embryos transfer
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Delivery of baby
Tidsram: 9 mounth after embryos transfer
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We are routinely report to the Israeli ministry of health all the children who were born from our treatment.
In this study we will calculate the number of children per thawed embryo transfer.
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9 mounth after embryos transfer
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Martha Dirnfeld, MD, Carmel Medical Center IVF Unit
Publikationer och användbara länkar
Allmänna publikationer
- Lahav-Baratz S, Koifman M, Shiloh H, Ishai D, Wiener-Megnazi Z, Dirnfeld M. Analyzing factors affecting the success rate of frozen-thawed embryos. J Assist Reprod Genet. 2003 Nov;20(11):444-8. doi: 10.1023/b:jarg.0000006705.46147.a2.
- Lahav-Baratz S, Shiloh H, Koifman M, Kraiem Z, Wiener-Megnazi Z, Ishai D, Dirnfeld M. Early embryo-endometrial signaling modulates the regulation of matrix metalloproteinase-3. Fertil Steril. 2004 Oct;82 Suppl 3:1029-35. doi: 10.1016/j.fertnstert.2004.06.026.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CMC-10-0010-CTIL
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