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

Not Applicable

Recruiting

• Conditions: Randomized Controlled Trial; Hyaluronan-EnRiched Medium
• Interventions: Other: use of hyaluronan-enriched transfer medium

• Registration Number: NCT04697823
• Lead Sponsor: KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-16
• Study Start: 2021-01-01
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-01-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	use of hyaluronan-enriched transfer medium	Patients receiving an embryo transfer in hyaluronan-enriched transfer medium

Primary Outcome Measures

Name	Time	Method
number of transfers needed to reach ongoing pregnancy	ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of 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.

Secondary Outcome Measures

Name	Time	Method
number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy	until Live birth: 9 months after ET	clinical pregnancy is defined as a pregnancy with at least one intrauterine (IU) or extrauterine (EU) fetal sac at 6-7 weeks of pregnancy)

Trial Locations

Locations (1)

Leuven University Fertility Center; 🇧🇪 Leuven, Belgium