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Fertility showdown: ICSI vs IVF – which works better?

NCT ID NCT07294027

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two common fertility treatments—ICSI and IVF—to see which one helps couples with unexplained infertility have a baby. About 848 couples in China will be randomly assigned to one treatment. The main goal is to find out which method leads to more live births.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 848 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 38 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 20-38 years 2. 18.5 \< BMI \< 24kg/m2 3. 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 4. First IVF/ICSI cycle 5. Received GnRH agonist protocol or GnRH antagonist protocol 6. Willing to provide informed consent and comply with follow-up Exclusion Criteria: 1. Preimplantation genetic testing (PGT) cycles 2. In vitro maturation (IVM) cycles 3. Using donor sperm/oocyte 4. Using frozen sperm/oocyte 5. \<5 oocytes retrieved 6. Abnormal semen parameters on the day of oocyte retrieval 7. High risk of tubal pathology or endometriosis without laparoscopic exclusion 8. Untreated or poorly controlled endocrine disorders 9. Abnormal immune related examinations 10. Major organ/system disorders (cardiac, hepatic, renal, oncologic, hematologic, psychiatric, etc.) 11. Concurrent participation in other clinical trials.

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unexplained infertility

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Huangshi Central Hospital

    Huangshi, Hubei, 435000, China

  • Jiaxing Maternity and Child Health Care Hospital

    Jiaxing, Zhejiang, 314051, China

  • Ningbo Women & Children's Hospital

    Ningbo, Zhejiang, 315012, China

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060, China

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310052, China

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.