- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02396095
Oocyte Cryopreservation Study (Egg Banking)
Live Birthrate Following Oocyte Cryopreservation
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Participants follow standard fertility protocols to stimulate the growth of multiple egg follicles. When the egg follicles are mature, the eggs will be removed under sedation, examined by an embryologist under a microscope and the mature eggs will be immediately frozen and kept frozen in tanks at Penn Fertility Care using the same methods of labeling and quality assurance currently in place for frozen embryos.
Eggs will be thawed in the future when the participant wishes to attempt pregnancy and fertilized by standard methods used during In Vitro Fertilization (IVF). Resulting embryos will be placed into the uterus by a procedure that will require approximately 15-30 minutes. The number of embryos to be transferred will be dictated by standard clinical practice. After embryo transfer, subjects will return for serum pregnancy tests at 14 days after the embryo transfer. For those who are not pregnant, there will be no further participation in the study. For those who do achieve pregnancy, trans-vaginal ultrasound will be performed at approximately 6 weeks gestation and weekly thereafter until 8 weeks gestation at which time, they will be referred to their general obstetrician for prenatal care. Participants will be asked to provide the study team with information about birthweight, height, length, gestational age at delivery, complications at delivery, and infant number. This information is routinely collected from patients undergoing conventional IVF in order to maintain quality assurance as recommended by the American Society of Reproductive Medicine. Information will also be collected from the participant's medical records including physical characteristics, medical and fertility history, semen analysis of the partner if appropriate, egg stimulation characteristics including medications, days of stimulation, number of egg follicles, number of mature and immature eggs retrieved, number of eggs frozen, number of eggs thawed, number of embryos, disposition of embryos, pregnancy test results, number of pregnancies that survived the first 12 weeks and prenatal screening tests.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104-5509
- University of Pennsylvania, Reproductive Research Unit
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- age between 15 and 45
- desire oocyte cryopreservation or use of cryopreserved oocytes for the purposes of achieving pregnancy
- willingness to participate in study and provide informed consent
Exclusion Criteria:
- day 3 FSH over 20 mIU/ml, or Day 3 E2 over 100pg/ml
- ovarian cyst greater than 14mm at baseline ultrasound
- uncontrolled medical illness such as diabetes, hypertension, or cardiovascular disease
- current pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Live birthrate following transfer of embryos created from frozen eggs
Tidsramme: 10 years
|
Live birthrate following transfer of embryos created from frozen eggs in the setting of: Autologous oocyte cryopreservation in women without cancer vs.autologous oocyte cryopreservation in women with cancer.
|
10 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Oocyte survival rates
Tidsramme: 10 years
|
The number of oocytes surviving cryopreservation, storage, and thaw will be evaluated.
|
10 years
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fertilization rates
Tidsramme: 10 years
|
Fertilization rates in each cohort will be compared.
|
10 years
|
Perinatal outcomes
Tidsramme: 10 years
|
Perinatal outcomes in each cohort will be evaluated including birth weight and gestational age at delivery.
|
10 years
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .