- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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).
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New Jersey
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Hasbrouck Heights, New Jersey, Forenede Stater, 07604
- University Reproductive Associates
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Hoboken, New Jersey, Forenede Stater, 07030
- University Reproductive Associates
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: In Vitro Maturation (IVM)
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
Tidsramme: 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
number of immature oocytes retrieved
Tidsramme: 6 months
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6 months
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rates of maturation and fertilization
Tidsramme: 6 months
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6 months
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Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Tidsramme: 6 months
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6 months
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live births
Tidsramme: 1 1/2 years
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1 1/2 years
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Peter G. McGovern, MD, Rutgers, the State University of New Jersey
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
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB 0120100297
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 .
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-
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