Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Sperm DNA damage may predict IVF success, new study aims to find thresholds

NCT ID NCT07621991

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will follow about 484 couples undergoing a type of IVF called ICSI to see if sperm DNA damage affects their chances of having a baby. Researchers will measure DNA breaks in sperm before and after a washing step, then track pregnancy and live birth rates. The goal is to find cutoff values that help doctors predict which couples are more likely to succeed.

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.

Participants

About 484 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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.

Who is studied

The study population will consist of infertile couples undergoing intracytoplasmic sperm injection (ICSI) at participating tertiary IVF centres in India. Inclusion and exclusion criteria have been defined to establish a relatively homogeneous study population suitable for evaluating the impact of double-strand sperm DNA fragmentation (dsSDF) and global sperm DNA fragmentation (SDF) on assisted reproductive technology (ART) outcomes while minimizing potential confounding factors related to severe male factor infertility, female reproductive pathology, and adjunctive fertility interventions.

Ages

21 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Males aged 21-55 years undergoing ICSI treatment for male factor infertility. * Women with age 21-35 for self-oocyte pickup cycles * Oocyte donor cycles with recipient age of 21-35 years of age * Sperm with a minimum total motile sperm count of 2.0 million/mL and a minimum volume of 1.2 mL * Patients not underwent sperm DNA fragmentation testing * 2-3 days of abstinence prior to intracytoplasmic sperm injection (ICSI). Exclusion Criteria: * Severe male factor infertility (azoospermia or severe oligozoospermia; for this study defined as no sperm present or sample with \<2 million/ml sperm count) * Known systemic diseases (e.g., diabetes mellitus). * Surgically retrieved sperms using testicular sperm aspiration, testicular sperm extraction and percutaneous epididymal sperm aspiration. * Untreated endometrial or uterine factors or adnexal pathology * Embryos underwent preimplantation genetic testing for aneuploidy testing. * Patients with thin endometrium (\<7mm) * Patients opted or underwent donor sperms as the male gamete source. * Patients underwent antioxidant treatment in last 6 months prior to ICSI treatment.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Male factor infertility are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

male infertility

As listed by the trial registrant

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

Sperm DNA fragmentation Sperm DNA impact on art outcomes

How to take part

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

  1. The places running it

    2 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

    Bangalore, Karnataka, 560041, India

  • Indira IVF Hospital

    Pune, Maharashtra, 411014, India

More trials for these conditions

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