Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06454058
Other study ID # INC-IIS-2024-004
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 14, 2024
Est. completion date January 2025

Study information

Verified date June 2024
Source Inception Fertility, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Advanced maternal age (AMA) is associated with a reduction in live birth rate (LBR) after ART cycles. The main reason for this reduction is the lower number of oocytes aspirated, the number of developing embryos and the low number of euploid embryos available for transfer. The impact of age on success rates after the transfer of an euploid embryo has been a matter of discussion, with a recent meta-analysis showing a reduction in LBR after the transfer of an euploid blastocyst to women of AMA (1). There could be many reasons for this reduced LBR but they can be categorized into two broad categories - the uterus (including the mother's health) and the embryo (including the oocyte and the sperm). It is possible that factors associated with reduced embryo quality would manifest in a lower embryo grade.


Description:

Objective: To study if there is an association between advanced maternal age and lower embryo grading of euploid embryos. Hypothesis: Advanced maternal age is associated with a lower embryonic grade in euploid embryos. Study Design: This is a retrospective cross-sectional study of euploid embryos from patients who have completed IVF with PGT-A testing at a fertility clinic in The Prelude Network (US sites only). A comparison of embryo grade between different age groups (<35, 40+) will be done after controlling for baseline demographic characteristics.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date January 2025
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU) - PGT biopsy was conducted in 2023, - PGT biopsy was performed on blastocyst stage embryo, - PGT-A result is euploid. Exclusion Criteria: - PGT-A result is mosaic, - Embryos in which PGT-M was done and were found to be carriers of the mutation, - Embryos in which PGT-SR was done and were found to be carriers of the structural rearrangement.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Inception Fertility, LLC Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Inception Fertility, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Embryo Grade Embryo grade for PGT-A confirmed euploid embryos 6 months
See also
  Status Clinical Trial Phase
Withdrawn NCT02759705 - Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)
Not yet recruiting NCT02534857 - A Study Comparing a Shorter Exposure of Oocyte to Spermatozoa Versus a Standard Incubation on the Live Birth Rate of In-vitro Fertilization Treatment N/A
Enrolling by invitation NCT01803893 - Prognostic Value of PIF Detection in Embryo Culture Media Correlation With Pregnancy Outcome N/A
Completed NCT01888744 - Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist Phase 4
Terminated NCT01173276 - Intrauterine Insemination In HIV-Discordant Couples N/A
Not yet recruiting NCT03680937 - Methods for Fertility Preservation: Impact of Vitrification on in Vitro Matured Oocytes
Completed NCT03455062 - Fertility Study of Women Who Received Organ Transplantation N/A
Completed NCT02736214 - Reproductive Life Plan-based Counseling With Men N/A
Terminated NCT01614704 - Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
Completed NCT01895192 - Sperm Morphology by High Magnification in Fertility Men N/A
Terminated NCT01268592 - Fertility Preservation in Female Cancer Patients N/A
Terminated NCT01232972 - Oocyte Cryopreservation N/A
Completed NCT01012596 - Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)
Completed NCT00390754 - Usefulness of Home Pregnancy Testing N/A
Completed NCT00231504 - Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count Phase 1
Completed NCT03345264 - The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study N/A
Recruiting NCT05414812 - Intervening on Women's Health for Rural Young Breast Cancer Survivors N/A
Active, not recruiting NCT02661932 - Fertility Preservation in Breast Cancer Patients Phase 4
Recruiting NCT06172504 - Ejaculation Frequency and Semen Parameters
Recruiting NCT02878434 - Fertility Preservation in Young Women With Cancer