ICSI Versus Conventional IVF in Couples With Unexplained Infertility

Официальное название

Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Unexplained Infertility: a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial

Обзор

This multicenter, open-label, parallel-group, randomized controlled trial aims to compare the live birth rate, fertilization outcomes, other pregnancy outcomes and safety between ICSI and conventional IVF among couples with unexplained infertility in China.

Подробное описание

A multicenter, large-scale, randomized controlled clinical trial will enroll 848 couples with unexplained infertility undergoing their first cycle of IVF or ICSI. The study will recruit participants from 6 Reproductive Medical Centers across mainland China. The participation in this study will be approximately 1 years with a total of 9 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to either the ICSI group or the IVF group in a 1:1 ratio. All participants will be randomized through block randomization, and each center will enroll participants using a competitive enrollment method.

Вмешательства

• Процедура ICSI
  Insemination will be performed by using ICSI, 2 hours after oocyte retrieval. COCs will be stripped by using hyaluronidase. Only matured oocytes (MII stage) will be injected. Fertilization check will be performed at period of 16-18 hours after injection. Other standard assisted reproductive treatments are similar and parallel between two groups.
• Процедура IVF
  Insemination will be performed by using conventional IVF, 2-4 hours after oocyte retrieval. Collected COCs will be inseminated (1-5×105 sperm/ml) and cultured overnight in culture medium. Fertilization check will be performed at period of 16-18 hours after insemination. If the IVF group experiences total fertilization failure or a fertilization rate of less than 25%, late rescue ICSI (Late-RICSI) will be performed on all MII stage oocytes using semen retained on the day of egg retrieval. The in

Первичные конечные точки

• Live birth rate after the first embryo transfer cycle [Срок оценки: At birth]

Вторичные конечные точки (12)

• Cumulative ongoing pregnancy rate within one year [Срок оценки: At 12 weeks of gestation; At 12 months after randomization]
• Number of retrieved oocyte [Срок оценки: 2 hours after oocyte retrieval]
• MII rate [Срок оценки: 2 hours after oocyte retrieval]
• Fertilization rate per oocyte inseminated/injected [Срок оценки: At 16-18 hours after insemination or injection]
• Fertilization rate per oocyte retrieved [Срок оценки: At 16-18 hours after insemination or injection]
• Normal fertilization rate [Срок оценки: At 16-18 hours after insemination or injection]
• Abnormal fertilization rate [Срок оценки: At 16-18 hours after insemination or injection]
• Degeneration rate of ICSI oocytes [Срок оценки: At 16-18 hours after injection]
• Cleavage rate [Срок оценки: At 16-18 hours after insemination or injection]
• Day 2 embryo formation rate [Срок оценки: 2 days after oocyte retrieval]
• Day 3 embryo formation rate [Срок оценки: 3 days after oocyte retrieval]
• Good quality embryo rate on Day 3 [Срок оценки: 3 days after oocyte retrieval]

Критерии участия

Критерии включения

• Aged 20-38 years
• 18.5 < BMI < 24kg/m2
• Couples diagnosed with primary unexplained infertility:

• Regular menses or confirmed ovulation;

• Normal ovarian reserve;

• Patent fallopian tubes;

• Normal uterus and cervix;

• Normal endocrine profile;

• Semen analysis meeting WHO 6th edition criteria

• Normal karyotypes in both partners, no family history of genetic disorders
• First IVF/ICSI cycle
• Received GnRH agonist protocol or GnRH antagonist protocol
• Willing to provide informed consent and comply with follow-up

Критерии исключения

• Preimplantation genetic testing (PGT) cycles
• In vitro maturation (IVM) cycles
• Using donor sperm/oocyte
• Using frozen sperm/oocyte
• <5 oocytes retrieved
• Abnormal semen parameters on the day of oocyte retrieval
• High risk of tubal pathology or endometriosis without laparoscopic exclusion
• Untreated or poorly controlled endocrine disorders
• Abnormal immune related examinations
• Major organ/system disorders (cardiac, hepatic, renal, oncologic, hematologic, psychiatric, etc.)
• Concurrent participation in other clinical trials.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Beijing Obstetrics and Gynecology Hospital, Capital Medical University — Пекин
• Huangshi Central Hospital — Huangshi
• Renmin Hospital of Wuhan University — Ухань
• Xiangyang Central Hospital — Xiangyang
• Second Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу
• Jiaxing Maternity and Child Health Care Hospital — Jiaxing
• Ningbo Women & Children's Hospital — Ningbo

Идентификаторы

NCT: NCT07294027 · 2025-0689

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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