RecruitingObservational

Improving hormonal infertility treatment for men with hypogonadotropic hypogonadism

This study called the 'HHF study' is looking back at anonymous medical records of men who have already received treatment for a specific type of male infertility called hypogonadotropic hypogonadism (HH). This condition affects around 1 in 2000 men where their bodies don't make enough hormones to produce sperm. While hormone injections can help, doctors don't yet know which treatment method, often called a 'recipe', works best for pregnancy. This study aims to find out which treatment 'recipe' is most successful, what other things affect pregnancy chances, and why some men might need further fertility help or experience side effects. No new patients are being recruited; the study will analyse existing data from hospitals worldwide.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

300

Start

01 Mar 2025

Estimated completion

31 Aug 2026

Infertility due to hypogonadism

What is this study about?

This study focuses on a condition called hypogonadotropic hypogonadism, or HH, which is a type of male infertility. Roughly 1 in 2000 men are affected by HH. It happens when the brain doesn't send the right signals (hormones) to the testicles to make sperm. The good news is that HH is currently the only type of male infertility that can often be treated with medication – specifically, hormone injections. These injections aim to help men produce enough sperm for their partners to become pregnant.

However, there isn't a clear understanding of which specific hormone treatment 'recipe' works best. Doctors use a few different approaches, and sometimes the injections don't work well enough on their own, meaning couples might need additional fertility treatments like IVF. Because these hormones are quite expensive, finding the most effective treatment is really important. This study will also look at other things that might affect the chance of pregnancy, such as the age of the female partner.

The main goal of this study is to look back at the information from men who have already received these hormone treatments. By carefully reviewing their medical records from specialist hospitals around the world, the researchers hope to figure out which treatment methods lead to the highest chance of pregnancy, what other factors play a role, and why some men might need extra help or experience side effects. This will help doctors give better advice and treatment to couples facing male infertility due to HH in the future.

Key takeaways

This study helps improve infertility treatment for men with a condition called HH.
It's a 'look-back' study using old, anonymous patient records, so no new patients are needed.
The goal is to find the most effective hormone treatment 'recipes' for pregnancy.
It also looks at other factors influencing pregnancy success and reasons for side effects.
Data is collected worldwide from specialist hospitals between 1995 and 2023.
The findings will help doctors offer better advice and care more effectively in the future.

Who may be eligible?

This study is not looking for new patients to take part. Instead, it's looking back at the medical records of men who have already been treated for a specific type of infertility called hypogonadotropic hypogonadism (HH).

To be included in the study, these men needed to have been diagnosed with HH, had very low sperm counts before treatment (less than 5 million sperm per millilitre), and received hormone injections between 1995 and 2023. They also needed to have been followed up for at least two years after starting treatment, or until their partner got pregnant, whichever came first.

The study would not include records from men who had other types of testicular problems, or those whose HH might have been caused by things like steroid use or severe obesity, as these situations can change how treatment works.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Has a diagnosis of hypogonadotropic hypogonadism (HH).
Had very low sperm counts before starting treatment (less than 5 million sperm per ml).
Received hormone injections for HH between 1995 and 2023.
Was followed up for at least 2 years after treatment, or until their partner became pregnant.
Did not have another type of testicular problem at the same time.
The cause of their HH was not due to things like anabolic steroids or severe obesity.

Answer every question to see your result.

What does participation involve?

This study doesn't involve you actively taking part or going to any appointments. Instead, researchers are looking back at information from medical records of men who have previously received gonadotrophin treatment for hypogonadotropic hypogonadism between 1995 and 2023. They will be asking doctors in specialist hospitals around the world to share anonymous details from patient records. This means your personal identity will not be shared. The researchers will then analyse this information to learn more about how well the treatments worked. There are no new assessments, medications, or follow-up visits involved for anyone.

Potential risks and benefits

Since this study only looks at anonymised medical records from patients who have already completed their treatment, there are no risks involved for anyone. There are also no direct benefits to individuals, as the study is reviewing past information. However, the information gathered is very important and will be used to improve how doctors care for and treat men with hypogonadotropic hypogonadism in the future, ultimately leading to better outcomes for similar couples.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
City only
London, England
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England
University College London Hospitals NHS Foundation Trust Hq
City only
London, England
Lothian NHS Board
City only
Edinburgh, Scotland
University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England
Unit for Gynecological and Andrological Endocrinology
Unverified
Milano, Italy
University of Modena and Reggio Emilia
Unverified
Modena, Italy
Istanbul University
Unverified
Fatih/İstanbul, Türkiye
Clinical Andrology
Unverified
Münster, Germany
Harvard University
Unverified
Cambridge, United States of America
Université Paris Saclay
Unverified
Gif-sur-Yvette, France
Concord Repatriation General Hospital
Unverified
Sydney, Australia

Common questions

What is hypogonadotropic hypogonadism (HH)?

It's a type of male infertility where the brain doesn't produce enough hormones to tell the testicles to make sperm.

Will I need to do anything if my records are included?

No, you don't need to do anything. The study uses existing, anonymised records, meaning your personal details won't be shared.

What will the study learn?

It aims to find the best hormone treatment methods for men with HH, what other factors help achieve pregnancy, and why some men might need further fertility treatments.

Is this study safe for patients?

Yes, it is very safe as it only involves looking at old, anonymous medical data. No patients are directly involved.

When will the study finish?

The study is expected to run from October 2023 until January 2028.

How to find out more

Bonnie Grant

b.grant@imperial.ac.uk +44 (0)20 7594 2489 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.