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Laser assisted hatching is beneficial for cases that use vitrified oocytes from egg donor cryo banks

Laser Assisted Hatching before embryo transfer improves the clinical outcome in Vitrified OOcyte Donation cycles: A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21836222
Enrollment
182
Registered
2017-01-31
Start date
2015-02-01
Completion date
Unknown
Last updated
2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oocyte donation and vitrification Pregnancy and Childbirth Oocyte donation and vitrification

Interventions

Participants are allocated to one of two groups. All embryos are made using vitrified oocytes from the IAKENTRO egg cryobank. All oocytes arevitrified and warmed using a closed system vitrification. A

Sponsors

IAKENTRO Advanced Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Oocyte donor inclusion criteria: 1. Up to 32 years old 2. Body mass index of less than 30 kg/m2 3. Regular menstrual cycles of 25–35 days 4. Two normal ovaries based on transvaginal scan findings 5. No polycystic ovary syndrome 6. No known endometriosis 7. No gynecological or medical disorders 8. Agreed to donate their oocytes for treatment anonymously and altruistically 9. Known fertility and good ovarian response 10. Blood sample given for karyotype and screening for previous viral infection (hepatitis B and C, human immunodeficiency virus, syphilis), thalassemia and cystic fibrosis 11. A single stimulation cycle was included for each donor Recipient inclusion criteria: 1. Up to 50 years old 2. No history of endometriosis 3. First oocyte donation cycle 4. Blood screening for karyotype and previous viral infections (hepatitis B and C, human immunodeficiency virus, syphilis,) thalassemia and cystic fibrosis, for both the recipient and their partners 5. Screened for hysterosalpingogram 6. Diagnostic hysteroscopy to eliminate cases presenting hydrosalpinx or intrauterine pathology 7. Receive a mock transfer in a cycle previous to their donation cycle and if difficulty was encountered a cervical dilatation was performed 8. The recipient’s partner has no severe male infertility indication

Exclusion criteria

Exclusion criteria: Vitrified egg donation exclusion criteria: 1. When warmed oocytes are less than 9 2. When survived oocytes after warming are less than 6 Recipient exclusion criteria: 1. More than 2 previous failed oocyte donation cycles 2. Severe male factor infertility in partner

Design outcomes

Primary

MeasureTime frame
1. Pregnancy rate per cycle is measured bythe rise of serum b-HCG concentrations through a blood test 14 days after embryo transfer 2. Clinical pregnancy rate per cycle, is assessed by the appearance of a gestational sac and a fetal heartbeat at 8–10 weeks of gestation 3. Ongoing pregnancy rate per cycle is assessed by the number of pregnancies with fetuses displaying heart activity beyond 12 weeks of gestation per cycle 4. Live birth rate per cycle by contacting the couple the estimated date of birth. The estimated due date is being calculated by the software we use in our clinic with patient information. A notification for calling the couple is being generated from the system automatically.

Secondary

MeasureTime frame
1. Implantation rate is measured by dividing the number of the gestational sacs that are being measured on 8th to 10th week of pregnancy, divided by the number of transferred embryos 2. Twin pregnancy rate is measured by dividing the number of the cases with 2 fetuses with the number of the cases with pregnancy. This information is being monitoring after 12 weeks of gestation.

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026