What side effects are associated with this type of intervention?

Selective Serotonin Reuptake Inhibitors (SSRIs) like Escitalopram, used in the treatment of male infertility, can have several side effects. Commonly reported side effects include sexual dysfunction (such as decreased libido, erectile dysfunction, and delayed ejaculation), gastrointestinal issues (nausea, diarrhea), insomnia, and weight changes. Additionally, SSRIs may cause psychological effects such as increased anxiety or mood swings. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically targeting male infertility that are similar to Escitalopram or other SSRIs. Treatments for male infertility typically focus on addressing underlying causes such as hormonal imbalances, varicocele repair, or assisted reproductive technologies like in vitro fertilization (IVF). While SSRIs like Escitalopram are primarily used for psychiatric conditions, they are not approved for treating male infertility.

What other types of research exist?

Promising alternatives to Escitalopram for male infertility patients include: 1) Bupropion, which has been studied for its effectiveness in treating depression without significant sexual side effects. 2) Psychological interventions such as Cognitive Behavioral Therapy (CBT) and mindfulness, which have shown effectiveness in reducing anxiety, depression, and distress related to infertility. These alternatives may offer benefits without the adverse impact on sperm quality associated with SSRIs.

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Selective Serotonin Reuptake Inhibitor

Escitalopram for Sperm DNA Fragmentation

Phase 2

Recruiting

Led By Jonathan Gal, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Current psychiatric disorder including: bipolar, mania, depression, generalized anxiety, social phobia, panic attacks, obsessive compulsive disorder, and schizophrenia

Family history of bipolar disorder, or suicide (including 2nd degree relatives)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 (baseline), 6, 10 weeks

Summary

This trial is testing the effects of escitalopram, a common antidepressant, on healthy men with normal fertility and no history of mental health issues. Researchers want to see if this medication affects sperm quality and overall fertility. The results will help doctors advise men who are concerned about fertility and are taking or considering taking escitalopram.

Who is the study for?

Men with normal or slightly low sperm counts who are not currently trying to conceive and have no psychiatric disorders, liver disease, family history of bipolar disorder or suicide. Participants must be able to engage in weekly sexual activity and provide semen samples throughout the 10-week study.

What is being tested?

The trial is testing if Escitalopram affects sperm DNA quality over a period of 6 weeks compared to a placebo. It's a double-blind study, meaning neither participants nor researchers know who gets the real drug. Measurements include hormone levels, semen analysis, and sexual function.

What are the potential side effects?

Potential side effects from Escitalopram may include nausea, headache, trouble sleeping, dry mouth, increased sweating, feeling nervous or restless; sexual side effects like reduced libido or difficulty achieving orgasm can also occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a diagnosed psychiatric condition like depression or anxiety.

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My family has a history of bipolar disorder or suicide.

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I am currently taking medication for mental health or seizures.

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I use sleeping pills.

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I use medication to improve sexual function.

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I have had chemotherapy or radiation to the pelvis.

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I have not used hormonal medications in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (baseline), 6, 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (baseline), 6, 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (baseline), 6, 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks

Secondary study objectives

Absolute change in sperm DNA fragmentation

Changes in concentration

Changes in progressive motility

+2 more

Other study objectives

Change in International Index of Erectile Function Survey

Change in serum follicle-stimulating hormone (FSH) (mIU/mL)

Change in serum luteinizing hormone (LH) (mIU/mL)

+2 more

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004

23%

Sleepiness/Sedation

10%

Headache

Tension/Inner Unrest

Reduced Salivation

Concentration Difficulties

Diminished Sexual Drive

Asthenia/Lassitude/Increased Fatigability

Constipation

Polyuria/Polydipsia

Orthostatic Dizziness

Nausea/Vomiting

Erectile Dysfunction

Failing Memory

Diarrhea

Increased Duration of Sleep

Reduced Duration of Sleep

Increased Dream Activity

Accomodation Disturbance

Increased Tendancy to Sweating

Weight Gain

Ejaculatory Dysfunction

Micturtion Disturbances

100%

80%

60%

40%

20%

Study treatment Arm

Escitalopram and Placebo

Escitalopram and Memantine

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EscitalopramExperimental Treatment1 Intervention

10mg by mouth daily for 6 weeks

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo control by mouth for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Escitalopram

2005

Completed Phase 4

~2330

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for male infertility include medications like Selective Serotonin Reuptake Inhibitors (SSRIs), which increase serotonin levels in the brain. While SSRIs like Escitalopram are primarily used to treat depression, they can negatively impact semen quality by increasing sperm DNA fragmentation and reducing sperm concentration and morphology. Other treatments, such as Coenzyme Q10 and L-carnitine, work by improving mitochondrial function and energy production in sperm cells, enhancing motility and overall sperm health. Follicle-stimulating hormone (FSH) and tamoxifen can stimulate sperm production and improve hormonal balance. Understanding these mechanisms is crucial for male infertility patients as it helps them and their doctors make informed decisions about treatment options that balance mental health needs with reproductive goals.

The antidepressant Sertraline inhibits CatSper Ca2+ channels in human sperm.The effect of SSRIs on Semen quality: A systematic review and meta-analysis.Effect of Venlafaxine, Pramipexole, and Valsartan on Spermatogenesis in Male Rats.