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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Banhā, Ägypten
- Elshrouk Fertility Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 360° Catheter Rotation
During embryo transfer, the catheter was withdrawn using a controlled 360° rotational movement.
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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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Aktiver Komparator: No Catheter Rotation
During embryo transfer, the catheter was withdrawn directly without rotational movement.
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Clinical Pregnancy Rate
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Chemical Pregnancy Rate
Zeitfenster: Approximately 14 days after embryo transfer
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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.
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Approximately 14 days after embryo transfer
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- embryo catheter rotation
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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