Not Yet RecruitingNot Applicable

ICSI Versus Conventional IVF in Couples With Unexplained Infertility

China848 participantsStarted 2026-01-01

Plain-language summary

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.

Who can participate

Age range20 Years – 38 Years

SexFEMALE

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Inclusion criteria

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

What they're measuring

Live birth rate after the first embryo transfer cycle

Timeframe: At birth

Trial details

NCT IDNCT07294027

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-30

Contact for this trial

Min Jin, PhD

+86-15925602121 min_jin@zju.edu.cn

View on ClinicalTrials.gov More Unexplained Infertility trials