Assisted HatchingNCT07490561
The Impact of Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients
A study testing Laser assisted hatching in people with Assisted Hatching and Advanced Age, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Assisted Hatching, Advanced Age
- What is being tested?
- Laser assisted hatching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 916 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Laser-Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients: A Randomized Controlled Trial
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 it aims to answer are:
Does laser assisted hatching improve the live birth rate in advanced age women undergoing vitrified-warmed embryo transfer? Does laser assisted hatching affect secondary outcomes including implantation rate, biochemical pregnancy rate, clinical pregnancy rate, ectopic pregnancy rate, ongoing pregnancy rate, miscarriage rate, multiple pregnancy rate, preterm birth rate, and rates of obstetric and neonatal complications as well as congenital anomalies? Researchers will compare the Laser Assisted Hatching (LAH) Group to the Control Group (without LAH) to see if LAH can improve pregnancy outcomes in the study population.
Read more
Participants will:
- Be randomly assigned to either the LAH Group or the Control Group at a 1:1 ratio, stratified by age (<40 years/≥40 years) and embryo stage (cleavage stage/blastocyst) using stratified block randomization.
- Undergo the first or second frozen-thawed embryo transfer cycle, with transferred embryos meeting the quality criteria (cleavage-stage embryos: Grade I, Grade II, or CP and above; blastocysts: 4BC/CB and above).
- Receive embryo vitrification and warming after routine fertilization and culture; LAH Group will undergo LAH (thinning zona pellucida for cleavage-stage embryos, removing 1/4-1/3 of zona pellucida circumference for blastocysts) in G2 medium after embryo thawing, while Control Group will not receive assisted hatching.
- Have endometrial preparation by natural, ovulatory, or hormone replacement cycles as appropriate, and 1-2 viable embryos will be transferred under ultrasound guidance within 3 hours after thawing, followed by routine luteal support after transfer.
- Complete follow-up at multiple time points: 12-15 days after embryo transfer (serum β-hCG test), 28 days after embryo transfer (transvaginal ultrasound), 12 weeks of gestation (ultrasound), 28 weeks of gestation (ultrasound), and 1 month after delivery (collection of delivery and neonatal information).
- Provide demographic, clinical, and embryological baseline data, as well as various outcome data during the study period.
- Undergo regular monitoring of vital signs, laboratory test results, and adverse events, with key prevention and control of specific risks related to LAH such as embryo damage and multiple pregnancy.
- Conditions
- Assisted Hatching, Advanced Age
- Being tested
- Laser assisted hatching
- Keywords
- Laser-Assisted hatching;, Vitrified-warmed embryo transfer, Frozen embryo transfer, Advanced maternal age, Infertility, IVF/ICSI, Live birth
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser assisted hatchingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser Assisted Hatching (LAH) Group | Experimental | 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. Receives: Procedure: Laser assisted hatching |
| Control Group (No AH) | No intervention | Embryos will undergo routine vitrification-warming and preparation without assisted hatching prior to transfer, and will be transferred within 3 hours after thawing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the delivery (≥28 weeks of gestation)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From enrollment to 28 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted HatchingStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 916 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490561
- Sponsor's protocol ID
- SH9H-2026-T42-2
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), along with the study protocol and statistical analysis plan, will be made publicly available via the National Clinical Research Data Sharing Platform (https://www.ncmc-data.org) within 12 months after study completion. The data will be accessible to qualified researchers in compliance with relevant laws, regulations, and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Laser-Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07490561
- Acronym / sponsor ID
- SH9H-2026-T42-2
- Conditions
- Assisted Hatching, Advanced Age
- Keywords
- Laser-Assisted hatching;, Vitrified-warmed embryo transfer, Frozen embryo transfer, Advanced maternal age, Infertility, IVF/ICSI, Live birth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 916 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 it aims to answer are:
Does laser assisted hatching improve the live birth rate in advanced age women undergoing vitrified-warmed embryo transfer? Does laser assisted hatching affect secondary outcomes including implantation rate, biochemical pregnancy rate, clinical pregnancy rate, ectopic pregnancy rate, ongoing pregnancy rate, miscarriage rate, multiple pregnancy rate, preterm birth rate, and rates of obstetric and neonatal complications as well as congenital anomalies? Researchers will compare the Laser Assisted Hatching (LAH) Group to the Control Group (without LAH) to see if LAH can improve pregnancy outcomes in the study population.
Participants will:
- Be randomly assigned to either the LAH Group or the Control Group at a 1:1 ratio, stratified by age (<40 years/≥40 years) and embryo stage (cleavage stage/blastocyst) using stratified block randomization.
- Undergo the first or second frozen-thawed embryo transfer cycle, with transferred embryos meeting the quality criteria (cleavage-stage embryos: Grade I, Grade II, or CP and above; blastocysts: 4BC/CB and above).
- Receive embryo vitrification and warming after routine fertilization and culture; LAH Group will undergo LAH (thinning zona pellucida for cleavage-stage embryos, removing 1/4-1/3 of zona pellucida circumference for blastocysts) in G2 medium after embryo thawing, while Control Group will not receive assisted hatching.
- Have endometrial preparation by natural, ovulatory, or hormone replacement cycles as appropriate, and 1-2 viable embryos will be transferred under ultrasound guidance within 3 hours after thawing, followed by routine luteal support after transfer.
- Complete follow-up at multiple time points: 12-15 days after embryo transfer (serum β-hCG test), 28 days after embryo transfer (transvaginal ultrasound), 12 weeks of gestation (ultrasound), 28 weeks of gestation (ultrasound), and 1 month after delivery (collection of delivery and neonatal information).
- Provide demographic, clinical, and embryological baseline data, as well as various outcome data during the study period.
- Undergo regular monitoring of vital signs, laboratory test results, and adverse events, with key prevention and control of specific risks related to LAH such as embryo damage and multiple pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Assisted Hatching (LAH) Group | Experimental | Procedure: Laser assisted hatchingLaser 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. |
| Control Group (No AH) | No intervention | –Embryos will undergo routine vitrification-warming and preparation without assisted hatching prior to transfer, and will be transferred within 3 hours after thawing. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser assisted hatchingLaser 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. | Procedure or surgery | Laser Assisted Hatching (LAH) Group |
Primary outcome
Live birth rate
Time frame: From enrollment to the delivery (≥28 weeks of gestation)
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).
12 secondary outcomes
Ongoing pregnancy rate
Time frame: From enrollment to 12 weeks of gestation
Biochemical pregnancy rate
Time frame: From enrollment to 12 days (blastocyst), 14 days (D3), or 15 days (D2) after embryo transfer
Ectopic pregnancy rate
Time frame: From enrollment to 28 days after embryo transfer
Neonatal complication rate
Time frame: From enrollment to 1 month after delivery
Macrosomia rate
Time frame: From enrollment to the delivery
Low birth weight rate
Time frame: From enrollment to the delivery
Miscarriage rate
Time frame: From enrollment to 28 weeks of gestation
Clinical pregnancy rate
Time frame: From enrollment to 28 days after embryo transfer
Preterm birth rate
Time frame: From enrollment to the delivery
Implantation rate
Time frame: From enrollment to 28 days after embryo transfer
Congenital malformation rate
Time frame: From enrollment to 1 month after delivery
Multiple pregnancy rate
Time frame: From enrollment to 28 days after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), along with the study protocol and statistical analysis plan, will be made publicly available via the National Clinical Research Data Sharing Platform (https://www.ncmc-data.org) within 12 months after study completion. The data will be accessible to qualified researchers in compliance with relevant laws, regulations, and ethical requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Laser assisted hatching in people with Assisted Hatching and Advanced Age, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SHUTIAN JIANG, Medical Doctor (021-23271699, shutiansweet@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: From enrollment to the delivery (≥28 weeks of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.