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The predictive effect of embryo morphology and cumulus cell miRNA panel on the outcome of transfer cycles of in vitro fertilization

Comparison of embryo selection based on embryo morphology and cumulus cell miRNA panel on clinical outcomes of single D3 embryo transfer: a prospective, randomized, controlled, single-center clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097377
Enrollment
Unknown
Registered
2025-02-18
Start date
2025-02-18
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Infertility

Interventions

morphological group:Embryo morphology was scored and embryos were selected for transfer.
miRNA group:The miRNA gene expression profile of cumulus cells was detected to select the embryo for transfer.

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
22 Years to 37 Years

Inclusion criteria

Inclusion criteria: 1) Age 22-38 years old (excluding 38 years old, calculated as the date of signing ICF during the screening period minus the birthday of the subject); 2) Normal ovarian reserve with bilateral AFC>=6 and AMH of 1.4-5.0ng/ml; 3) Menstrual cycle: 21-35 days (including boundary value); 4) Using an antagonist protocol and recombinant FSH as gonadotropin; 5) Fertilization by IVF; 6) =8; 8) D3 high-quality embryos >=2; 9) Consent for elective D3 fresh single embryo transfer; 10) Subjects voluntarily signed ICF; 11) The first fresh or first frozen-thawed transfer cycle of each subject.

Exclusion criteria

Exclusion criteria: 1) Patients with recurrent miscarriage (>=2 previous miscarriages); 2) Polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria; 3) Patients with uterine fibroids (submucosal fibroids >3cm or intramural fibroids affecting uterine cavity shape), untreated endometrial polyps, endometrial hyperplasia, intrauterine adhesions, uterine malformations, ASRM stage III-IV endometriosis, and hydrosalpinx that may affect the clinical outcome of transplantation; 4) Mate with severe oligospermia and asthenospermia (sperm concentration 30% or obstructive azoospermia (donor sperm could not be excluded for these criteria); 5) Chromosomal abnormalities in men or women, except for polymorphism; 6) Other conditions that are not suitable for conventional IVF treatment according to clinical routine; 7) Those who were deemed unsuitable for the study by the investigators.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate per transfer;

Secondary

MeasureTime frame
Live birth rate per transfer;Ongoing pregnancy rate per transfer;Miscarriage rate;

Countries

China

Contacts

Public ContactXuefeng Huang

The First Affiliated Hospital of Wenzhou Medical University

xuefhuang@126.com+86 577 55578055

Outcome results

None listed

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