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

NCT ID: NCT04697823

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hyaluronan-EnRiched Medium Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
double blind

Study Groups

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study group

Patients receiving an embryo transfer in hyaluronan-enriched transfer medium

Group Type ACTIVE_COMPARATOR

use of hyaluronan-enriched transfer medium

Intervention Type OTHER

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

control group

Patients receiving an embryo transfer in conventional culture medium

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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use of hyaluronan-enriched transfer medium

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

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Sophie Debrock

clinical embryologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Leuven University Fertility Center

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Sophie Debrock, PhD

Role: CONTACT

0032016340812

Facility Contacts

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Sophie Debrock, PhD

Role: primary

Other Identifiers

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S64387

Identifier Type: -

Identifier Source: org_study_id

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