CircularRNA-microRNA-mRNA Regulatory Axis in IVF

NCT06792266 | Not Yet Recruiting

• 1 other identifier: CircularRNA-microRNA-mRNA axis
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Investigate the expression levels of circ-0033392, miR-375, miR-1305, JAK2, and PTEN in follicular fluids of females candidate for IVF.
2. 2.Correlate the expression levels of measured biomarkers to the pregnancy rate and live birth rate.
3. 3.Correlate the expression levels of the measured biomarkers with the embryological outcome which is the oocyte maturity rate, fertilization rate, embryo cleavage rate and blastocyst formation rate and implantation rate.

Conditions

Infertility (IVF Patients)

Outcome Measures

Primary Outcomes (2)

• levels of biomarkers

  Measure the expression of circ-0033392, miR-375, miR-1305, JAK2 and PTEN in follicular fluid samples from females prior to IVF.

  at time of egg retrieval

• Correlate biomarkers

  Correlate the expression levels of measured biomarkers to the pregnancy rate and live birth rate.

  ≥ 8 weeks after embryo transfer and follow up of pregnant females until delivery

Secondary Outcomes (1)

• Correlate biomarkers with embryological outcomes

  at time of oocyte retrieval until embryo transfer

Study Arms (1)

infertile females prior to IVF

females diagnosed with idiopathic or male factor infertility. Follicular fluid samples will be obtained from all females following ovarian stimulation. Mature oocytes will be collected 34-36 h after human chorionic gonadotropin injection. Clinical follow up after embryo transfer, if the outcome will be a positive pregnancy test or clinical pregnancy with a fetal heartbeat at ≥ 8 weeks, the follicular fluid samples will be classified into the pregnancy group (I). In the absence of pregnancy, the samples will be classified as non-pregnancy group (ӀӀ)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

females prior to IVF from attendants of IVF unit of Women's Health Hospital, Assiut university hospital, Assiut university.

You may qualify if:

• Females age \<40 years with male factor or idiopathic infertility.
• Females undergo embryo transfer of blastocysts after intracytoplasmic sperm injection (ICSI) or conventional in vitro fertilization (IVF)

You may not qualify if:

• Patients with structural and tissue abnormalities or infectious etiologies in the uterus and adnexa
• Women with risk factors or diseases that could influence oocyte quality, such as women with body mass index ≥35 kg/m2, a diagnosis of polycystic ovarian syndrome or endometriosis or diminished ovarian reserve.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Medical Biochemistry and Molecular Biology Department, Faculty of Medicine, Assuit University, Assuit, Egypt.

Asyut, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

follicular fluid samples from a single follicle \>18 mm will be collected and centrifuged at 1500×g for 15 min to separate the serum fraction debris; the supernatant will be stored at -80 °C for further use.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Lamia Ahmed Ibrahim, assisstant lecturer

CONTACT

00201019956057; lamiaahmed43@yahoo.com

Abdel-Halim Ali Abdel-Halim, professor

CONTACT

00201220507051

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 24, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)