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Classic Congenital Adrenal HyperplasiaFERTI-HCSNCT06153043

Fertility and Pregnancy in Patients With Classic Congenital Adrenal Hyperplasia

An observational study of Classic Congenital Adrenal Hyperplasia, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Classic congenital adrenal hyperplasia (CAH) is a rare genetic endocrine disorder. Its prevalence is around 1/15.000. It results from a deficiency in 21-hydroxylase, an adrenal steroidogenic enzyme involved in the biosynthesis of cortisol and aldosterone. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Classic Congenital Adrenal Hyperplasia
What is being tested?
Women patients with classical congenital adrenal hyperplasia
How many people
56 participants
Where
1 siteFrance
Study dates
16 Jan 2024to 16 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: This study will focus on patients in the Endocrinology department of the Louis Pradel Hospital in Bron, suffering from a classic form of Congenital Adrenal Hyperplasia by enzymatic block.

Who may be able to join

  • for patient :
  • Adult patient > 18 years
  • Classical congenital adrenal hyperplasia (21-hydroxylase deficiency, 11β-hydroxylase deficiency and 3βHSD2 deficiency)
  • Who have indicated that they do not object to participating in the sudy
  • For partners :
  • No objection to the collection of their fertility data

Who cannot join

  • Non classical congenital adrenal hyperplasia
  • Classical congenital adrenal hyperplasia due to other enzyme block

Trial locations and contacts

1 site in 1 country.

France1 site
  • Endocrinology Department of Louis Pradel Hospital

    Bron, 69677

Other trials in France

About this study

Classic congenital adrenal hyperplasia (CAH) is a rare genetic endocrine disorder. Its prevalence is around 1/15.000. It results from a deficiency in 21-hydroxylase, an adrenal steroidogenic enzyme involved in the biosynthesis of cortisol and aldosterone. Enzyme deficiency in the steroideogenesis pathway leads to cortisol and aldosterone deficiency of varying severity, and to the accumulation of precursors (17OHP and Progesterone), which are diverted to the production of androgens (Testosterone and D4AD).

There are two clinical forms of classical CAH : the salt wasting form and the simple virilizing form, depending on the degree of aldosterone deficiency.

Read more

The clinical signs are adrenal insufficiency and hyperandrogenism. Hyperandrogenism manifests itself during foetal life, and may be responsible for virilization of the external genitalia of a female foetus, of varying severity.

The challenge in managing this condition is to find the right therapeutic balance. Hydrocortisone and fludrocortisone supplementation must be adapted to control adrenal insufficiency, and limit hyperandrogenism. It must be sufficient to avoid episodes of acute adrenal insufficiency, but not excessive to avoid complications secondary to hypercorticism.

During childhood, this balance is necessary for growth and pubertal development. However, this balance is difficult to achieve and maintain over time.

In adulthood, the fertility of patients is an important issue. This one remains poorly understood.

It was only after the introduction of cortisol supplementation in the treatment of CAH in the 1950s that the first pregnancies were described. Since when, due to the rarity of the pathology, the number of pregnancies studied has remained low, and the literature has little hindsight on the subject.

This pathology has long been associated with female infertility, due to many factors : biological, mechanical, psychological and sexual, among others. Biological hyperandrogenism may be responsible for chronic dysovulation, and may render the endometrium unsuitable for embryonic implantation. The virilization of the external genitalia and possible complications of pelvic surgery can be an obstacle to sexuality in these patients. They experience sexual difficulties, particularly during penetrative intercourse. The literature also shows that the majority of these patients are single and that their sexual orientation is more likely to be homosexual. Finally, the desire to have children is less prevalent in these patients than in the general population.

The first published studies on the fertility of CAH patients showed a lower pregnancy rate than the general population, but did not take into account the patient' desire to become pregnant.

In 2009, Casteras et al demonstrated for the first time in a cohort of CAH patients that fecundity is preserved in patients with a desire to become pregnant.

It should be noted that the fertility of patients with CAH may evolve in the coming years in France thanks to the new bioethics law voted in 2021, which now allows unmarried patients and patients in homosexual couples to have access to male gamete donation.

In addition, very little is known about the course of pregnancies in patients with CAH. Few pregnancies have been studied to date.

Hormonal balance during pregnancy if difficult to monitor, given the absence of reliable biological makers during this period. In this context, it is complicated to know the impact of the pathology and its balance on the course of the pregnancy.

The latest articles published on the subject of pregnancy complications are contradictory. Some find an increased risk of gestational diabetes. Others find a higher risk of maternal-fetal infection, low weight for gestational age, or congenital malformations than in general population. The increased risk of miscarriage is debated.

On the other hand, articles are unanimous on the most frequent mode of delivery in this population : in the vast majority of cases, patients give birth by ceasarian section, due to their history of pelvic surgery.

It is in context that we wish through this study to make a point of fertility and pregnancy in patients with classical CAH.

Being tested
Women patients with classical congenital adrenal hyperplasia
Keywords
Classic congenital adrenal hyperplasia, fertility, fecundity, pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Women patients with classical congenital adrenal hyperplasiaOther

    The Easily and Médifirst medical files of these patients will be studied in order to collect the desired variables. If the files are incomplete, and if data concerning fertility, pregnancy, and the characteristics of the newborn are missing, patients will be contacted to ask them to answer the questionnaire to obtain this information.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe the fertility of classical CAH women patients who had a desire for pregnancy and sought to conceive

    Proportion of patients who have had at least one pregnancy, regardless of outcome, among patients who have had a desire for pregnancy and have tried to conceived

    Measured: At inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2023
  2. Study start16 Jan 2024
  3. Primary completion16 Feb 2024
  4. Study completion16 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06153043
Sponsor's protocol ID
69HCL23_1153
Other IDs
2023-A02432-43
Acronym
FERTI-HCS
Status last verified
Feb 2024
First submitted
22 Nov 2023
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Classic Congenital Adrenal Hyperplasia, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe the fertility of classical CAH women patients who had a desire for pregnancy and sought to conceive (time frame: At inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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