- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01237106
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)
In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study
This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment.
In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New Jersey
-
Hasbrouck Heights, New Jersey, Forente stater, 07604
- University Reproductive Associates
-
Hoboken, New Jersey, Forente stater, 07030
- University Reproductive Associates
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
- 10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form.
- A diagnosis of PCOS by their primary MD
- An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion
- A day 3 FSH level of <8 IU/mL
- In good general health off of current medications which may confound response to study medications.
- Desire to seek pregnancy actively during the study period by IVF-ICSI.
- A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
- Male partner able to provide adequate semen sample by ejaculation (no TESE)
Exclusion Criteria
- Current pregnancy
- Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
- Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL).
- Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
- Patients with significant anemia (Hemoglobin < 10 mg/dL).
- Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
- have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) -
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: In Vitro Maturation (IVM)
|
all patients in this pilot study will undergo IVM.
IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
number of immature oocytes retrieved
Tidsramme: 6 months
|
6 months
|
|
rates of maturation and fertilization
Tidsramme: 6 months
|
6 months
|
|
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Tidsramme: 6 months
|
6 months
|
|
live births
Tidsramme: 1 1/2 years
|
1 1/2 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Peter G. McGovern, MD, Rutgers, The State University of New Jersey
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB 0120100297
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