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Whole cytoplasmic replacement at zygote stage (day 1 embryo) for the treatment of infertility

Pronuclear transplantation (PNT) in patients with repeated failure following assisted reproduction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58459168
Enrollment
30
Registered
2021-05-01
Start date
2015-09-23
Completion date
Unknown
Last updated
2023-04-24

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

Conditions

Recurrent implantation failure associated with poor embryo development that cannot be overcome by standard IVF Urological and Genital Diseases

Interventions

Patient and donor are usually stimulated simultaneously via standard stimulation protocols in order to achieve simultaneous oocyte retrieval and fertilization. In some instances, follicular stimulatio

Sponsors

Nadiya Clinic
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. No less than two failed previous IVF attempts with preimplantation embryonic lethality (embryo arrest) 2. Low blastulation rates 3. Low number or absence of euploid embryos

Exclusion criteria

Exclusion criteria: 1. Fertile patients 2. Fertile homosexual female couples 3. Male factor infertility

Design outcomes

Primary

MeasureTime frame
1. Blastocyst rate measured using a non-invasive time-lapse imaging system on Day 5 – Day 7 post insemination 2. Euploidy rate measured via aCGH or NGS analysis of trophectoderm biopsy from embryos on Day 5 – Day 7 post insemination 3. Clinical pregnancy rate measured by rising beta hCG levels starting at 10 days post embryo transfer, presence of gestational sac at 6-7 weeks post embryo transfer, and presence of fetal heartbeat at 6-7 weeks post embryo transfer 4. Health of baby at birth and long-term follow-up, assessed by pediatrician examination on a yearly basis for the first 7 years, and then on a bi-yearly basis until age 18. This includes periodic completion of a quality of life questionnaire related to the offspring produced in the clinical trial

Secondary

MeasureTime frame
Miscarriage rates calculated from the patients who delivered babies to the total number of patients scored as clinically pregnant based on the primary outcome measure 3, calculated each month, quarter and annually

Countries

Ukraine

Outcome results

None listed

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