ICSI Versus Conventional IVF in Couples With Unexplained Infertility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICSI, IVF.
- Who it may be relevant to
- Registry conditions: Unexplained Infertility. Basic parameters: 20 years — 38 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Unexplained Infertility: a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Procedure 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. - Procedure 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
Primary outcome measures
- Live birth rate after the first embryo transfer cycle [Time frame: At birth]
Secondary outcome measures (12)
- Cumulative ongoing pregnancy rate within one year [Time frame: At 12 weeks of gestation; At 12 months after randomization]
- Number of retrieved oocyte [Time frame: 2 hours after oocyte retrieval]
- MII rate [Time frame: 2 hours after oocyte retrieval]
- Fertilization rate per oocyte inseminated/injected [Time frame: At 16-18 hours after insemination or injection]
- Fertilization rate per oocyte retrieved [Time frame: At 16-18 hours after insemination or injection]
- Normal fertilization rate [Time frame: At 16-18 hours after insemination or injection]
- Abnormal fertilization rate [Time frame: At 16-18 hours after insemination or injection]
- Degeneration rate of ICSI oocytes [Time frame: At 16-18 hours after injection]
- Cleavage rate [Time frame: At 16-18 hours after insemination or injection]
- Day 2 embryo formation rate [Time frame: 2 days after oocyte retrieval]
- Day 3 embryo formation rate [Time frame: 3 days after oocyte retrieval]
- Good quality embryo rate on Day 3 [Time frame: 3 days after oocyte retrieval]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 7 centers
- Beijing Obstetrics and Gynecology Hospital, Capital Medical University — Beijing
- Huangshi Central Hospital — Huangshi
- Renmin Hospital of Wuhan University — Wuhan
- Xiangyang Central Hospital — Xiangyang
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
- Jiaxing Maternity and Child Health Care Hospital — Jiaxing
- Ningbo Women & Children's Hospital — Ningbo
Identifiers
NCT: NCT07294027 · 2025-0689