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New study aims to boost IVF success by testing smarter sperm selection

NCT ID NCT07626359

Knowledge-focused Sponsor: Indira IVF Hospital Pvt Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at two ways to prepare sperm for IVF in men with high sperm DNA damage. One method uses a second ejaculate collected shortly after the first, and the other uses a special device that picks the healthiest sperm without spinning them. The goal is to see which method leads to more pregnancies. About 830 couples will take part.

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 830 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 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

21 to 45 years

Sex

Anyone

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: * • Elevated SDF defined as DFI \>20 %measured by the sperm chromatin dispersion (SCD) test performed in a participating center's andrology laboratory, using a harmonized protocol under standardized conditions after 2-3 days of ejaculatory abstinence, and within 90 days (≤3 months) prior to enrollment. * Male partners 21-45 years; * Female partners 21-35 years. * Undergoing IVF/ICSI. * No known genetic or chromosomal abnormalities. * Minimum 4 MII oocyte patients shall be included Exclusion Criteria: * Azoospermia or severe oligoasthenozoospermia (\<1 million motile sperm/mL). * Significant systemic disease (e.g., uncontrolled diabetes, malignancy). * History of a prior ICSI cycle with no embryo development. * Relevant female factors: untreated adnexal pathology ,a history of a thin endometrium (\<7 mm) following endometrium preparation for embryo transfer

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As listed by the trial registrant

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

Male

How to take part

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

  1. The places running it

    9 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

  • Indira IVF Hospital Limited

    Bangalore, Karnataka, 560078, India

  • LAB

    Udaipur, Rajasthan, 313001, India

  • Recruitment

    Patna, Bihar, 800014, India

  • Recruitment

    Bhāndup, Maharashtra, India

  • Recruitment

    Pune, Maharashtra, India

  • Recruitment

    Delhi, National Capital Territory of Delhi, India

  • Recruitment

    Jaipur, Rajasthan, India

  • Recruitment

    Allahābād, Uttar Pradesh, India

  • Recruitment

    Lucknow, Uttar Pradesh, India

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