Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

Официальное название

Use of Hyaluronic Acid-enriched Transfer Medium in Women Undergoing Single Blastocyst Transfer : a Multicenter, Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат High Hyaluronic Acid concentrations (0.5 mg/ml)
  Hyaluronic Acid(EmbryoGlue®)
• Биопрепарат Low Hyaluronic Acid concentrations (0.125 mg/ml)
  Hyaluronic Acid (G2 medium)

Первичные конечные точки

• Live birth rate [Срок оценки: Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.]

Вторичные конечные точки (12)

• Biochemical pregnancy [Срок оценки: 12 days after embryo transfer.]
• Clinical pregnancy [Срок оценки: 6-8 weeks after embryo transfer]
• Ongoing pregnancy [Срок оценки: after 12 weeks of gestation.]
• Miscarriage [Срок оценки: 20 weeks of gestation.]
• Ectopic pregnancy [Срок оценки: After 4 to 6 weeks of embryo transfer]
• Multiple pregnancy [Срок оценки: 7 weeks of gestation.]
• hypertensive disorders in pregnancy [Срок оценки: From 20 weeks of gestation up to at birth]
• Placental implantation disorders [Срок оценки: From 20 weeks of gestation up to at birth]
• Preterm birth [Срок оценки: At birth]
• Preterm premature rupture of membranes [Срок оценки: Before 37 weeks of gestation and before the onset of labor]
• Mode of delivery [Срок оценки: At birth]
• Gestational age [Срок оценки: At birth]

Критерии участия

Критерии включения

• All cycles with single blastocyst transfer will be considered eligible
• Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes
• No age restriction will be applied
• Informed consent was signed

Критерии исключения

• Uterine anatomic anomalies
• Women with untreated hydrosalpines
• Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• IVF laboratory — Сиань

Публикации

• Cai H, Xu D, Wang Z, Huang B, Xue X, Bai H, Man Y, Lei D, Wu Q, Ni Y, Lei J, Shi J. Efficacy and safety of hyaluronic acid-enriched transfer medium in women undergoing single blastocyst transfer: a study protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Nov 19;15(11):e104571. doi: 10.1136/bmjopen-2025-104571. PMID 41263844

Идентификаторы

NCT: NCT06492785 · 2024-127

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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