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

Randomized Controlled Trial Clinical Trial

— TETHER  

Official title:

Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04697823
• Other study ID #: S64387
• Status: Recruiting
• Phase: N/A
• 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
• 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:

-

Related Conditions & MeSH terms

• Hyaluronan-EnRiched Medium
• Randomized Controlled Trial

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