بيتا
رادار التجارب AI
حالة التجربة السريرية NCT07490561 لـ Assisted Hatching، Advanced Age هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث

The Impact of Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients ٩١٦ وقاية

لم يبدأ القبول بعد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07490561 هي دراسة تدخُّلية لـAssisted Hatching، Advanced Age وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ٢٧ رمضان ١٤٤٧ هـ لتجنيد ٩١٦ مشاركًا. يقودها Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University، ومن المتوقع اكتمالها بحلول ٣ شعبان ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٥ شوال ١٤٤٧ هـ.
الملخص
The goal of this clinical trial is to evaluate the effect of laser assisted hatching (LAH) on pregnancy outcomes, with live birth rate as the primary outcome, in advanced age infertile women aged ≥35 years who are undergoing non-donor IVF/ICSI cycles and planning vitrified-warmed embryo transfer. It also aims to monitor the safety of LAH and assess various secondary pregnancy and neonatal outcomes. The main questions...عرض المزيد
العنوان الرسمي

The Impact of Laser-Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients: A Randomized Controlled Trial

الحالات الطبية
Assisted HatchingAdvanced Age
معرّفات دراسة أخرى
  • SH9H-2026-T42-2
NCT معرّف
NCT07490561
تاريخ البدء (فعلي)
2026-03-16
آخر تحديث مُنشور
2026-03-24
تاريخ الاكتمال (المقدر)
2027-12-31
عدد المشاركين المخطط لهم
٩١٦
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
Laser-Assisted hatching;
Vitrified-warmed embryo transfer
Frozen embryo transfer
Advanced maternal age
Infertility
IVF/ICSI
Live birth
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
تجريبيةLaser Assisted Hatching (LAH) Group
Laser assisted hatching will be performed on vitrified-warmed embryos prior to embryo transfer according to standard laboratory procedures. For cleavage-stage embryos, the zona pellucida will be thinned; for blastocysts, 1/4-1/3 of the zona pellucida circumference will be removed, and the operation will be performed in G2 medium after embryo thawing.
Laser assisted hatching
Laser assisted hatching will be performed on vitrified-warmed embryos prior to embryo transfer according to standard laboratory procedures. For cleavage-stage embryos, the zona pellucida will be thinned; for blastocysts, 1/4-1/3 of the zona pellucida circumference will be removed, and the operation will be performed in G2 medium after embryo thawing.
بدون تدخلControl Group (No AH)
Embryos will undergo routine vitrification-warming and preparation without assisted hatching prior to transfer, and will be transferred within 3 hours after thawing.
غ/م
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Live birth rate
Live birth rate is defined as the proportion of all enrolled participants who achieved a live birth, defined as the delivery of a live infant at ≥28 weeks of gestation with any signs of life (e.g., heartbeat, respiration).
From enrollment to the delivery (≥28 weeks of gestation)
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Ongoing pregnancy rate
The proportion of participants enrolled in the study who experienced an ongoing pregnancy, defined as the confirmation of an intrauterine viable fetus via ultrasound examination at 12 weeks of gestation.
From enrollment to 12 weeks of gestation
Biochemical pregnancy rate
The proportion of participants enrolled in the study who experienced a biochemical pregnancy, defined as a serum HCG level ≥25 IU/L measured 14 or 15 days after embryo transfer.
From enrollment to 12 days (blastocyst), 14 days (D3), or 15 days (D2) after embryo transfer
Ectopic pregnancy rate
The proportion of participants enrolled in the study who experienced an ectopic pregnancy, defined as the detection of an extrauterine gestational sac (including heterotopic pregnancy) via ultrasound examination after embryo transfer.
From enrollment to 28 days after embryo transfer
Neonatal complication rate
The proportion of participants who achieved a live birth and delivered a newborn with neonatal complications.
From enrollment to 1 month after delivery
Macrosomia rate
The proportion of participants who achieved a live birth and delivered a newborn with a birth weight of ≥4000g.
From enrollment to the delivery
Low birth weight rate
The proportion of participants who achieved a live birth and delivered a newborn with a birth weight of less than 2500g.
From enrollment to the delivery
Miscarriage rate
The proportion of participants who experienced a clinical pregnancy and subsequently had a spontaneous pregnancy loss before 28 weeks of gestation.
From enrollment to 28 weeks of gestation
Clinical pregnancy rate
The proportion of participants enrolled in the study who experienced a clinical pregnancy, defined as the confirmation of an intrauterine gestational sac via ultrasound examination 28 days after embryo transfer.
From enrollment to 28 days after embryo transfer
Preterm birth rate
The proportion of participants who achieved a live birth and delivered between 28 and 36⁺⁶ weeks of gestation.
From enrollment to the delivery
Implantation rate
The proportion of all transferred embryos that developed into an intrauterine gestational sac, as confirmed by ultrasound examination 28 days after embryo transfer.
From enrollment to 28 days after embryo transfer
Congenital malformation rate
The proportion of participants who achieved a live birth and delivered a newborn diagnosed with a congenital malformation according to the International Classification of Diseases (ICD-10).
From enrollment to 1 month after delivery
Multiple pregnancy rate
The proportion of participants enrolled in the study diagnosed with multiple pregnancy, defined as the confirmation of ≥2 intrauterine gestational sacs via ultrasound examination 28 days after embryo transfer.
From enrollment to 28 days after embryo transfer
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ
العمر الأدنى للدراسة
35 Years
الجنس المؤهل
أنثى
  • 1: Female age ≥ 35 years
  • 2: First or second vitrified-warmed embryo transfer cycle
  • 3: Quality of embryos for transfer meeting the criteria: Grade I, II, CP or above (cleavage-stage embryos); Grade 4BC/CB or above (blastocysts)
  • 4: Provide written informed consent

  • 1: Use of donor oocytes or sperm, or planned preimplantation genetic testing (PGT)
  • 2: Severe immune or chromosomal abnormalities
  • 3: Uterine cavity abnormalities (i.e., adenomyosis, submucous uterine fibroids, hydrosalpinx, uterine septum, and endometrial polyps)
  • 4: Embryos with an abnormal zona pellucida
  • 5: Complicated with severe underlying diseases (e.g., uncontrolled hypertension/diabetes mellitus, active malignant tumors)
  • 6: A history of recurrent implantation failure (≥2 cycles) or recurrent miscarriage (≥2 episodes)
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University logoShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
جهة اتصال مركزية للدراسة
جهة اتصال: SHUTIAN JIANG, Medical Doctor, 021-23271699, [email protected]
لا توجد بيانات موقع.