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Scientists probe link between obesity and infertility

NCT ID NCT02653092

Knowledge-focused Sponsor: University of Colorado, Denver 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 investigates how obesity-related factors like high insulin and fat levels may disrupt fertility in women. Researchers will measure hormone changes and metabolic responses in 84 women. The goal is to understand the underlying causes and inform future treatments to improve reproductive outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Insulin, Intralipid, Dextrose, Heparin, GnRH, and Hyperinsulinemic Euglycemic Clamp procedure
What this could lead to
If successful, this research could point toward new ways to improve fertility in women with obesity by targeting metabolic issues.
What could go wrong
This is an early observational study, not a treatment trial. It may not lead to direct benefits, and results may not apply to all women.

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

84 people

The number who actually took part.

Started

Jun 2016

Expected to finish

Dec 2026

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

18 to 38 years

Sex

Female participants only

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: * Body Mass Index (BMI) at least 18 but less than 25 kg/m2 * No history of chronic disease affecting hormone production, metabolism, or clearance * No use of medications known to alter or interact with reproductive hormones or insulin metabolism (e.g. thiazolidinediones, metformin) * No use of reproductive hormones within 3 months of enrollment * Normal prolactin and thyroid stimulating hormone levels at screening * History of regular menstrual cycles every 25-35 days * Use of a reliable method of contraception (female or male partner sterilization; intra uterine device (IUD); abstinence; diaphragm) * Normal hemoglobin A1c * Screening hemoglobin \>11gm/dl Exclusion Criteria: * Women with a baseline dietary assessment indicative of \>35% daily calorie consumption from fat (as calculated based upon initial screening survey) will be excluded, as the impact of increasing their dietary fat intake may be minimal. * Women with fasting triglycerides \>300mg/dl at screening will be excluded, as they might be at risk for acute elevation of triglycerides and even pancreatitis if placed on a high fat diet * Inability to comply with the protocol. Individuals who travel frequently, or who eat most of their meals outside of their home will be excluded, as it will be difficult to impossible for them to comply with the diet, to pick up the food cartons, etc. * Because high proportions of dairy fat will be needed to attain 48% calories from fat in the diet, vegans and lactose intolerant individuals will be excluded. * Pregnant women or women planning to become pregnant will be excluded.

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Conditions

The condition(s) this trial relates to.

hyperinsulinism hypogonadotropic hypogonadism infertility disorder Obesity obesity disorder

As listed by the trial registrant

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

Hyperinsulinemia Hypogonadotropic hypogonadotropism Infertility Obesity

Contacts and locations

Locations

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

More trials for these conditions

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