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

• Sponsor: KU Leuven (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04697823
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyaluronan-EnRiched Medium; Randomized Controlled Trial	Other: use of hyaluronan-enriched transfer medium	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: double blind
• Primary Purpose: Treatment
• Official Title: Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: study group Patients receiving an embryo transfer in hyaluronan-enriched transfer medium	Other: use of hyaluronan-enriched transfer medium; In the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium
No Intervention: control group Patients receiving an embryo transfer in conventional culture medium

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leuven University Fertility Center	Leuven		Belgium	3000

Sponsors and Collaborators

• KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sophie Debrock, clinical embryologist, KU Leuven
• ClinicalTrials.gov Identifier: NCT04697823
• Other Study ID Numbers: S64387
• First Posted: Jan 6, 2021
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyaluronic Acid

Study Results

No Results Posted as of Mar 11, 2022