Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate.

NCT04697823 | Recruiting

• 1 other identifier: S64387
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyaluronan-EnRiched Medium; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy

  until Live birth: 9 months after ET

Study Arms (2)

study group

ACTIVE COMPARATOR

Patients receiving an embryo transfer in hyaluronan-enriched transfer medium

Other: use of hyaluronan-enriched transfer medium

control group

NO INTERVENTION

Patients receiving an embryo transfer in conventional culture medium

Interventions

use of hyaluronan-enriched transfer medium OTHER

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

study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Leuven University Fertility Center

Leuven, 3000, Belgium

RECRUITING

Central Study Contacts

Sophie Debrock, PhD

CONTACT

0032016340812; sophie.debrock@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical embryologist

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 6, 2021
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

BE (1)