- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03105323
Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome
This study will be conducted at the In vitro fertilization Unit at Ain Shams University Maternity Hospital.
Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study The study will assess Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm Injection outcome.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Blood samples were collected on the day of final oocyte maturation, and serum Progesterone levels were measured using a chemiluminescent immunoassay for quantitative determination of the hormone .
The P/F ratio was calculated according to the equation (P(ng/mL)/number of follicles) and was defined by the measurements obtained on the day of final oocyte maturation.
All ultrasounds were performed at our In vitro fertilization center, and we included the number of follicles ≥14mm on the day of final oocyte maturation in the ratio calculation Oocytes were retrieved 36 hours after injection and were subsequently fertilized by In vitro fertilization or Intra cytoplasmic sperm injection. On day 2 - 5, all embryos were evaluated for cell number and morphology.
Each embryo transferred was evaluated for blastomere size and fragmentation. Embryos were graded as follows. Those with equal blastomere size and no fragmentation were considered Grade 1; those with blastomeres of equal size with slight fragmentation (<20 %) were Grade 2;those with blastomeres of unequal size but no fragmentation were Grade 3; those with blastomeres of equal or unequal size and moderate fragmentation (20 %-50 %) were Grade 4; and those with unrecognizable blastomeres and severe fragmentation (>50 %) were Grade 5.
The embryos were transferred on postretrieval day (2 - 5). Pregnancy was defined by Human chorionic gonadotropin titers within 11 days following Embryo transfer. Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
This study will be conducted at the IVF Unit at Ain Shams University Maternity Hospital.
Women will be recruited from the IVF Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
Beschrijving
Inclusion Criteria:
- Women with any type of subfertility undergoing IVF treatment.
- Age between (20-40) years old
- Body mass index between (20-40)
- Selected embryo are of grade 1 and 2 quality.
Exclusion Criteria:
- Age above 40 years old
- BMI above 40
- Bad quality embryo
- Uterine anomalies or malformation that affect embryo transfer.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
infertile women
All patients were pretreated with Gonadotropin releasing hormone agonist (decapeptyl®) 0.05 mg/day from 10 days prior to the start of menstruation.
The patients'ovaries were stimulated with a recombinant follicle-stimulating hormone (FSH, subcutaneous) from day 2 of the menstrual cycle.
human chorionic gonadotropin was administered when at least two follicles vary 18-22mm were observed on ultrasonography.Blood samples were collected on the day of final Human chorionic gonadotropin maturation, and serum P levels were measured.Pregnancy was defined by titers within 11 days following Embryo transfer,Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
clinical pregnancy rate
Tijdsspanne: a year
|
rate of incidence of pregnancy after Intracytoplasmic Sperm Injection
|
a year
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Ain Shams University (Register-ID: passant abdalla)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .