- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01219387
Evaluation of Anti-mullerian Hormone Levels as Predictive of IVF Outcomes in Women Over 38 Years Old
Evaluation of Serum Anti-Mullerian Hormone (AMH) and Inhibin B Levels as Early Predictors of a Successful IVF Cycle in Women Over 38 Years Old.
Studieoversikt
Status
Detaljert beskrivelse
Specifics aims are: a) to describe AMH and inhibin levels on day 3 previous to ART cycle; b) to analyze the association between these hormone levels and the retrieved metaphase II oocytes quantity; c) to analyze the association between these hormone levels and quality embryo score d) to analyze the association between these hormone levels and the number of gestational sacs per transferred-embryo (implantation rate); e) to analyze the association between these hormone levels and the pregnancy rate; f) to make a prediction model for pregnancy rate by using a multivariable regression analysis.
Patient participation includes signing the consent and having additional tubes of blood drawn at a regularly scheduled blood draw. This blood is used to run the study tests (AMH and inhibin levels).
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
New Jersey
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Morristown, New Jersey, Forente stater, 07960
- Reproductive Medicine Assoicates of New Jersey
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Pennsylvania
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Allentown, Pennsylvania, Forente stater, 18104
- Reproductive Medicine Associates of PA at Lehigh Valley
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
1. Women 38 years old or older at the time of initiating treatment
Exclusion Criteria:
- Uterine disease: malformation, septum, submucosal myomas, endometrial polyps Advanced endometriosis with endometrioma (s)
- No uterus
- Single ovary
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
AMH levels as predictive of oocyte quality
Tidsramme: within 3 months
|
Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and the oocyte quality as observed during the IVF cycle
|
within 3 months
|
|
AMH levels as predictive of embryo quality
Tidsramme: within 3 months
|
Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and the embryo quality as observed during the IVF cycle
|
within 3 months
|
|
AMH levels as predictive of implantation and pregnancy outcomes
Tidsramme: 1 year
|
Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and rates of implantation and delivery during that IVF cycle
|
1 year
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Paul A Bergh, MD, Reproductive Medicine Associates of new Jersey
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- RMA-00-09
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