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Clinical Trial NCT07490561 for Assisted Hatching, Advanced Age is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Impact of Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients 916 Prevention

Not yet recruiting
Clinical Trial NCT07490561 is an interventional study for Assisted Hatching, Advanced Age and is currently not yet recruiting. Enrollment is planned to begin on 16 March 2026 and continue until the study accrues 916 participants. Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, this study is expected to complete by 31 December 2027. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief Summary
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...Show More
Official Title

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

Conditions
Assisted HatchingAdvanced Age
Other Study IDs
  • SH9H-2026-T42-2
NCT ID Number
NCT07490561
Start Date (Actual)
2026-03-16
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
916
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Laser-Assisted hatching;
Vitrified-warmed embryo transfer
Frozen embryo transfer
Advanced maternal age
Infertility
IVF/ICSI
Live birth
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalLaser 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.
No InterventionControl 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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
35 Years
Eligible Sexes
Female
  • 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
Study Central Contact
Contact: SHUTIAN JIANG, Medical Doctor, 021-23271699, [email protected]
No location data.