Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

Northwest Women's and Children's Hospital, Xi'an, Shaanxi858 enrolled

Overview

The purpose of this study is to compare the live birth rates of high concentration of Hyaluronic Acid (0.5 mg/ml) transfer medium (EmbryoGlue®) to those containing low Hyaluronic Acid concentrations (0.125 mg/ml) (G2 medium) in women undergoing single fresh and frozen blastocyst transfer.

The single blastocyst-stage embryo transfer cycles will be randomised in a 1:1 allocation, with block sizes of 2 and 4 on the day of Embryo Transfer (ET). This randomisation process will be centrally managed via a web-based electronic data capture system and will be stratified according to the treatment center. The allocation sequence and the designated treatment will be completely concealed from the participating couples, clinicians - including those conducting the transfer procedures - and outcome assessors. Given the intrinsic viscous nature of EmbryoGlue, embryologists, who who are responsible for the procedures in the laboratory will not be subjected to blinding. Only at the end of the study, when data collection is completed, the allocation sequence will be revealed to the primary investigators.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

858

Conditions

Infertility

Interventions

High Hyaluronic Acid concentrations (0.5 mg/ml)BIOLOGICAL

Hyaluronic Acid(EmbryoGlue®)

Low Hyaluronic Acid concentrations (0.125 mg/ml)BIOLOGICAL

Hyaluronic Acid (G2 medium)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. All cycles with single blastocyst transfer will be considered eligible 2. Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes 3. No age restriction will be applied 4. Informed consent was signed Exclusion Criteria: 1. Uterine anatomic anomalies 2. Women with untreated hydrosalpines 3. Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.

Locations (1)

IVF laboratory

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

Live birth rate

The primary outcome was Live birth rate per embryo transfer.

Time frame: Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.

Secondary Outcomes

Biochemical pregnancy

Biochemical pregnancy is defined as serum beta-human chorionic gonadotropin β-hCG \> 20 IU/L 12 days after embryo transfer.

Time frame: 12 days after embryo transfer.

Clinical pregnancy

Clinical pregnancy is defined as the presence of at least one gestational sac confirmed by ultrasonography (ectopic pregnancy is included as a clinical pregnancy).

Time frame: 6-8 weeks after embryo transfer

Ongoing pregnancy

Ongoing pregnancy is defined as the presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.

Time frame: after 12 weeks of gestation.

Miscarriage

Miscarriage is defined as spontaneous loss of an intrauterine pregnancy before 20 completed weeks of gestation.

Time frame: 20 weeks of gestation.

Ectopic pregnancy

Ectopic pregnancy is defined as a pregnancy implanted outside the uterine cavity, diagnosed by ultrasonography, surgical visualization, or histopathology.

Time frame: After 4 to 6 weeks of embryo transfer

Multiple pregnancy

Multiple pregnancy is defined as a pregnancy with two or more gestational sacs or fetal heartbeats at 7 weeks of gestation.

Time frame: 7 weeks of gestation.

Central Contacts

He Cai, Doctor

CONTACT

13581613908 caihe@bjmu.edu.cn

Data from ClinicalTrials.gov

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