Infertility, FemaleNACRENCT03349190
Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques
An observational study of Infertility, Female and Fibroid Uterus, run by ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO at 23 sites in 2 countries.
Trial summary
Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility would be due to the mechanical way. The interest of the resection of intramural fibroids is discussed. It is necessary to measure the indication of a myomectomy, whatever the surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility, Female, Fibroid Uterus
- What is being tested?
- ULIPRISTAL ACETATE
- How many people
- 127 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 29 Dec 2017to 8 Jan 2019
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women with fibroids managed with assisted reproduction techniques (ART)
Who may be able to join
- Age between 18 to 43 years 'old at the time of the beginning of ulipristal acetate intake
- Women with fibroid at the time of ulipristal acetate prescription
- Women with desire to have children and managed for infertility in an ART center (whatever the type of infertility treatment)
- Women having received a treatment by ulipristal acetate
- Data collected between 2013/12/01 and 2018/06/30 ; data collected between ulipristal acetate prescription until the term of pregnancy or embryo transfer failure (up to 4) or death/lost to follow up or ART treatment discontinuation
Who cannot join
- none
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
France22 sites
Chu Angers
Angers
Chu Besancon
Besançon
Chu Pellegrin
Bordeaux
Polyclinique Jean Villar
Bruges
Centre Hospitalier Intercommunal Creteil
Créteil
Chu Dijon
Dijon
Clinique Val D'Ouest
Écully
Chru Lille
Lille
Cpma Marseille
Marseille
Imr Rocca
Marseille
Chevalier
Montpellier
POUGET
Montpellier
CHU NICE
Nice
Chu Nimes
Nîmes
Ch Antoine Beclere
Paris
CH TENON
Paris
Maternite Bichat
Paris
MENARD
Paris
Port Royal - Chirurgie
Paris
Chu Rennes
Rennes
Cmco - University Hospitals of Strasbourg
Schiltigheim
Chu Toulouse
Toulouse
New Caledonia1 site
Centre Hospitalier Territorial Gaston Bourret
Noumea
About this study
Official title: A Retrospective, National, Multicenter Study Evaluating the Impact of Ulipristal Acetate (Esmya®) on Infertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques (ART)
Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility would be due to the mechanical way.
The interest of the resection of intramural fibroids is discussed. It is necessary to measure the indication of a myomectomy, whatever the surgical procedure. On the one hand, it may cause important potential complications, and on the other hand, the surgery does not improve the parameters of the fertility.
Read more
Thus, it is a major stake to avoid the surgical operation. A decrease of the size of these fibroids by medical treatment is then a good option.
When the surgical treatment is necessary, a medical pre-surgical treatment is often proposed in order to decrease the symptomatology and to reduce the size of the fibroid to facilitate the surgery.
Acetate Ulipristal (UPA) has been marketed in this indication. Following the Pearl I-II studies, the first indication in France was a pre-surgical treatment for 3 months at a dose of 5 mg per day.
The Pearl III and IV studies evaluated the Esmya® administration as a long-term intermittent repeated treatment, giving to it a prominent position for the long-term management of symptomatic fibroids.
Furthermore, cases of pregnancy before surgery are frequently described in women with fibroids treated by UPA for a pre-IVF surgery.
5 to 10 % of women who are managed for infertility have fibroids and only 2% to 3% have this unique cause of infertility.
Then, some of patients followed in ART centers have been treated by UPA to reduce the fibroids size and/or to decrease the associate symptoms.
The aim of this study is to evaluate in the different French ART centers, the impact on fertilization of UPA administration for infertile women with fibroids and to describe the modalities of its prescriptions and to collect information regarding safety tolerance profile of Esmya® in this patient population.
Read the detailed description
A retrospective, national, multicenter study
- Conditions
- Infertility, Female, Fibroid Uterus
- Being tested
- ULIPRISTAL ACETATE
- Medical subject headings
- Infertility, Female, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULIPRISTAL ACETATEDrug
Ulipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study)
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Clinical pregnancy rate after maximum 4 embryos transferred by IVF/ICSI procedures ; pregnancy is defined by beta-hCG> 1000 or presence of a gestation sac
Measured: 15 days
Secondary outcomes (8)
Spontaneous pregnancy
Spontaneous pregnancy rate before first embryo transferred by IVF/ICSI procedures; pregnancy is defined by beta-hCG > 1000 or presence of a gestation sac
Measured: at least 2 months
Live birth / miscarriage
Live birth rate / miscarriage rate
Measured: 9 months
Fibroids size
Fibroids size reduction
Measured: Baseline (before ulipristal acetate administration) and 20 months
Surgery rate
Rate of surgery
Measured: 3 months
Surgery description
Description of the surgery type and surgery indication
Measured: 3 months
Description of ulipristal acetate prescription
Reasons of the prescription, type of fibroids concerned, number of cycles of treatment, treatment duration
Measured: 20 months
Safety impact on ulipristal acetate administration
Review of adverse drug reactions resulting in ulipristal acetate treatment modification or discontinuation
Measured: 20 months
Ulipristal acetate safety analysis in infertile women with fibroids
Review of all serious adverse reactions (expected or unexpected) in this population
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start29 Dec 2017
- Primary completion30 Jun 2018
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO
- Sponsor type
- University, hospital or other
- Collaborators
- Gedeon Richter Plc.
- Responsible party
- Principal investigator, Catherine Rongieres, ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO
- Investigators
- Catherine RONGIERES, MD, Principal investigator, ADEFIV & University Hospitals of Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349190
- Sponsor's protocol ID
- 0001
- Acronym
- NACRE
- Status last verified
- Jan 2019
- First submitted
- 10 Nov 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, National, Multicenter Study Evaluating the Impact of Ulipristal Acetate (Esmya®) on Infertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques (ART)
- ClinicalTrials.gov ID
- NCT03349190
- Acronym / sponsor ID
- NACRE / 0001
- Conditions
- Infertility, Female, Fibroid Uterus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITROUniversity, hospital or other
- Collaborators
- Gedeon Richter Plc.
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility would be due to the mechanical way.
The interest of the resection of intramural fibroids is discussed. It is necessary to measure the indication of a myomectomy, whatever the surgical procedure. On the one hand, it may cause important potential complications, and on the other hand, the surgery does not improve the parameters of the fertility.
Thus, it is a major stake to avoid the surgical operation. A decrease of the size of these fibroids by medical treatment is then a good option.
When the surgical treatment is necessary, a medical pre-surgical treatment is often proposed in order to decrease the symptomatology and to reduce the size of the fibroid to facilitate the surgery.
Acetate Ulipristal (UPA) has been marketed in this indication. Following the Pearl I-II studies, the first indication in France was a pre-surgical treatment for 3 months at a dose of 5 mg per day.
The Pearl III and IV studies evaluated the Esmya® administration as a long-term intermittent repeated treatment, giving to it a prominent position for the long-term management of symptomatic fibroids.
Furthermore, cases of pregnancy before surgery are frequently described in women with fibroids treated by UPA for a pre-IVF surgery.
5 to 10 % of women who are managed for infertility have fibroids and only 2% to 3% have this unique cause of infertility.
Then, some of patients followed in ART centers have been treated by UPA to reduce the fibroids size and/or to decrease the associate symptoms.
The aim of this study is to evaluate in the different French ART centers, the impact on fertilization of UPA administration for infertile women with fibroids and to describe the modalities of its prescriptions and to collect information regarding safety tolerance profile of Esmya® in this patient population.
Detailed description
A retrospective, national, multicenter study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women with fibroids managed with assisted reproduction techniques (ART)
Key inclusion criteria (5 listed)
- Age between 18 to 43 years 'old at the time of the beginning of ulipristal acetate intake
- Women with fibroid at the time of ulipristal acetate prescription
- Women with desire to have children and managed for infertility in an ART center (whatever the type of infertility treatment)
- Women having received a treatment by ulipristal acetate
- Data collected between 2013/12/01 and 2018/06/30 ; data collected between ulipristal acetate prescription until the term of pregnancy or embryo transfer failure (up to 4) or death/lost to follow up or ART treatment discontinuation
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ULIPRISTAL ACETATEUlipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study) | Drug | – |
Primary outcome
Clinical pregnancy
Time frame: 15 days
Clinical pregnancy rate after maximum 4 embryos transferred by IVF/ICSI procedures ; pregnancy is defined by beta-hCG> 1000 or presence of a gestation sac
8 secondary outcomes
Spontaneous pregnancy
Time frame: at least 2 months
Live birth / miscarriage
Time frame: 9 months
Fibroids size
Time frame: Baseline (before ulipristal acetate administration) and 20 months
Surgery rate
Time frame: 3 months
Surgery description
Time frame: 3 months
Description of ulipristal acetate prescription
Time frame: 20 months
Safety impact on ulipristal acetate administration
Time frame: 20 months
Ulipristal acetate safety analysis in infertile women with fibroids
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine RONGIERES, MD principal investigator
ADEFIV & University Hospitals of Strasbourg
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Fibroid Uterus, run by ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO at 23 sites in 2 countries.
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 5 inclusion and 1 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, New Caledonia. 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?
Clinical pregnancy (time frame: 15 days). 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 9 Jan 2019.