Embryo Transfer Catheter Rotation Effect on Pregnancy Rate
Prospective Randomized Controlled Trial Comparing Catheter Rotation and no Rotation During Embryo Transfer on Pregnancy Outcome
The goal of this clinical trial was to determine whether rotating the embryo transfer catheter through 360° during its withdrawal improves pregnancy outcomes in women aged 20-35 years undergoing fresh day-3 embryo transfer as part of assisted reproductive treatment. The main questions it aimed to answer were:
Does 360° catheter rotation during withdrawal increase the clinical pregnancy rate, defined as the ultrasound confirmation of an intrauterine gestational sac? Does 360° catheter rotation during withdrawal increase the chemical pregnancy rate, defined by a positive pregnancy test?
Researchers compared embryo transfer with 360° catheter rotation during catheter withdrawal with embryo transfer without catheter rotation to determine whether this technique improves pregnancy outcomes.
Participants were:
Undergoing controlled ovarian stimulation, oocyte retrieval, fertilization, and fresh transfer of two day-3 embryos.
Being randomly assigned to either 360° catheter rotation during withdrawal or standard catheter withdrawal without rotation.
Undergoing pregnancy testing after embryo transfer. Undergoing an ultrasound examination to confirm clinical pregnancy if the pregnancy test was positive.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Banhā, Egypt
- Elshrouk Fertility Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Women aged 20-35 years. Body mass index (BMI) less than 40 kg/m². Undergoing fresh day-3 embryo transfer. First embryo transfer cycle. Transfer of two grade A embryos. Willingness to participate and provision of written informed consent.
Exclusion Criteria:
- Diabetes mellitus, hypertension, thyroid disorders, or other significant systemic diseases.
Male-factor infertility. Endometriosis. Uterine-factor infertility, including uterine fibroids, adenomyosis, uterine septum, cesarean scar niche, or endometrial polyps.
Difficult embryo transfer. Poor ovarian response.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 360° Catheter Rotation
During embryo transfer, the catheter was withdrawn using a controlled 360° rotational movement.
|
Participants underwent fresh day-3 embryo transfer.
In the experimental arm, the catheter was rotated 360° during withdrawal.
In the comparator arm, the catheter was withdrawn without rotation.
|
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Aktiv komparator: No Catheter Rotation
During embryo transfer, the catheter was withdrawn directly without rotational movement.
|
Participants underwent fresh day-3 embryo transfer.
In the experimental arm, the catheter was rotated 360° during withdrawal.
In the comparator arm, the catheter was withdrawn without rotation.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Pregnancy Rate
Tidsramme: Approximately 4-5 weeks after embryo transfer
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The proportion of participants with an intrauterine gestational sac confirmed by transvaginal ultrasound after embryo transfer.
Clinical pregnancy rate was calculated as the number of participants with a confirmed clinical pregnancy divided by the total number of participants in each study arm, multiplied by 100.
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Approximately 4-5 weeks after embryo transfer
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Chemical Pregnancy Rate
Tidsramme: Approximately 14 days after embryo transfer
|
The proportion of participants with a positive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test after embryo transfer.
Chemical pregnancy rate was calculated as the number of participants with a positive pregnancy test divided by the total number of participants in each study arm, multiplied by 100.
|
Approximately 14 days after embryo transfer
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- embryo catheter rotation
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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