- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07832825
Effect of Body Mass Index on ICSI Outcomes
Effect of Body Mass Index on Intracytoplasmic Sperm Injection Cycles
This retrospective cohort study aims to evaluate the effect of body mass index on the outcomes of intracytoplasmic sperm injection (ICSI) cycles at Assiut Women Health Hospital.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Obesity is associated with alterations in reproductive function and may affect the success of assisted reproductive techniques. This observational study will review medical records of women who underwent ICSI cycles.
Patients will be classified according to the World Health Organization body mass index categories: underweight (<18.5 kg/m²), normal weight (18.5-24.99 kg/m²), overweight (25-29.99 kg/m²), and obese (≥30 kg/m²). Pregnancy outcomes will be compared across BMI groups.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Hager M Mohamed, Resident
- Telefonnummer: 01554546780
- E-mail: hagar.18313516@med.aun.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Women who underwent intracytoplasmic sperm injection cycles at Assiut Women Health Hospital between January 2020 and December 2026.
Beskrivelse
Inclusion Criteria:
- Women who underwent ICSI cycles at Assiut Women Health Hospital
- Recorded weight and height at the start of treatment
Exclusion Criteria:
- Cases with no recorded weight or height at registration
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Underweight
BMI < 18.5 kg/m² Women classified according to World Health Organization body mass index categories who underwent ICSI cycles. |
|
Normal weight
BMI 18.5-24.99 kg/m² Women classified according to World Health Organization body mass index categories who underwent ICSI cycles. |
|
Overweight
BMI 25-29.99 kg/m² Women classified according to World Health Organization body mass index categories who underwent ICSI cycles. |
|
Obese
BMI ≥ 30 kg/m² Women classified according to World Health Organization body mass index categories who underwent ICSI cycles. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Pregnancy Rate After ICSI
Tidsramme: At 6 weeks after embryo transfer
|
Proportion of women achieving clinical pregnancy defined as positive serum beta-hCG and presence of gestational sac on ultrasound among total ICSI cycles stratified by BMI groups |
At 6 weeks after embryo transfer
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ongoing Pregnancy Rate
Tidsramme: At 12 weeks after embryo transfer
|
Proportion of pregnancies continuing beyond 12 weeks gestation among women who achieved clinical pregnancy stratified by BMI groups |
At 12 weeks after embryo transfer
|
|
Clinical Abortion Rate
Tidsramme: Up to 20 weeks after embryo transfer
|
Proportion of clinical pregnancies that result in pregnancy loss before 20 weeks gestation among BMI groups |
Up to 20 weeks after embryo transfer
|
|
Live Birth Rate
Tidsramme: At 40 weeks after embryo transfer
|
Proportion of ICSI cycles resulting in live birth among BMI groups |
At 40 weeks after embryo transfer
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Ahmed N Fatieh, prof, obstetric and gynecology Department, Assiut University Hospitals
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BMI-ICSI-Assiut-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .