Half-dose vs Conventional-dose Cetrorelix in ICSI Cycles
Half-dose Versus Conventional-dose Cetrorelix in Antagonist ICSI Cycles: Prospective Comparative Cohort Study
This prospective cohort study aims to compare the effectiveness of half-dose (0.125 mg/day) versus conventional-dose (0.25 mg/day) cetrorelix in GnRH antagonist ICSI cycles regarding clinical pregnancy rate in women with BMI ≥25 kg/m².
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Cetrorelix is used as a GnRH antagonist to prevent premature LH surge during controlled ovarian stimulation for ICSI. This observational study will include women aged less than 35 years with normal ovarian reserve and BMI ≥25 kg/m² who received either half-dose or conventional-dose cetrorelix as part of routine care. Clinical pregnancy rate and secondary reproductive outcomes will be compared between the two groups.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Samar A Mohy eldin, Resident
- Telefonnummer: 01142926439
- E-mail: samarmohy42@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Women aged less than 35 years with BMI ≥25 kg/m² and normal ovarian reserve who received either half-dose or conventional-dose cetrorelix as part of routine care during GnRH antagonist ICSI cycles at Assiut University Hospital.
Beskrivelse
Inclusion Criteria:
- - Age less than 35 years
- Normal ovarian responders (AMH ≥1.2 ng/mL and AFC 5-15)
- Body mass index (BMI) ≥25 kg/m²
- Written informed consent
Exclusion Criteria:
- - Age greater than 35 years
- Diminished ovarian reserve (AMH <1.2 ng/mL or AFC <5)
- Congenital uterine anomalies or significant intrauterine pathology
- Contraindications to ovarian stimulation or pregnancy
- Refusal to participate
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Half-dose Cetrorelix 0.125 mg
Women who received cetrorelix 0.125 mg daily as part of routine GnRH antagonist protocol. |
|
Conventional-dose Cetrorelix 0.25 mg
Women who received cetrorelix 0.25 mg daily as part of routine GnRH antagonist protocol. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Pregnancy Rate
Tidsramme: 6 weeks after embryo transfer
|
Proportion of women with intrauterine gestational sac with fetal heartbeat by ultrasound at 6 weeks gestation |
6 weeks after embryo transfer
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ongoing pregnancy rate
Tidsramme: 12 weeks after embryo transfer
|
Ongoing pregnancy with heartbeat >12 weeks on ultrasound |
12 weeks after embryo transfer
|
|
Number of retrieved oocytes
Tidsramme: Periprocedurally, at time of oocyte retrieval, during oocyte pickup procedure
|
Mean number of oocytes retrieved at pickup |
Periprocedurally, at time of oocyte retrieval, during oocyte pickup procedure
|
|
Number of mature MII oocytes
Tidsramme: Periprocedurally , at time of oocyte retrieval, Day 0, during oocyte pickup procedure
|
Mean number of mature MII oocytes |
Periprocedurally , at time of oocyte retrieval, Day 0, during oocyte pickup procedure
|
|
Fertilization rate
Tidsramme: 1 day after ICSI
|
Fertilized oocytes / MII oocytes |
1 day after ICSI
|
|
Premature LH surge
Tidsramme: Baseline (before hCG trigger)
|
LH >=10 IU/L or progesterone >=1.0 ng/mL before trigger |
Baseline (before hCG trigger)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Mohamed S Abdallah, prof, obstetrics 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
- CETRO-ICSI-Assiut-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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