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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04697823
Other study ID # S64387
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source KU Leuven
Contact Sophie Debrock, PhD
Phone 0032016340812
Email sophie.debrock@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 31, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Patients with own oocytes/embryos; - Patients with female age at 1st OR in the study <40 year; - Patients planned for a 2nd oocyte retrieval, with no clinical ongoing pregnancy after the previous oocyte retrieval - Patients planned for a 3rd oocyte retrieval with no clinical ongoing pregnancy after previous oocyte retrievals - Patients with female age at 1st OR in the study <40 year; - Patients with BMI =32; - Patients with written informed consent; Exclusion Criteria: -

Study Design


Intervention

Other:
use of hyaluronan-enriched transfer medium
In the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium

Locations

Country Name City State
Belgium Leuven University Fertility Center Leuven

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of transfers needed to reach ongoing pregnancy The primary outcome parameter is the number of transfers needed to reach ongoing pregnancy (ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy), as a time-to-event outcome variable. Patients that do not reach pregnancy, are censored at their last transfer. ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy
Secondary number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy clinical pregnancy is defined as a pregnancy with at least one intrauterine (IU) or extrauterine (EU) fetal sac at 6-7 weeks of pregnancy) until Live birth: 9 months after ET
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