Fibroid; Uterus Tumor, Complicating PregnancyNCT04028986
Esmya Versus Surgery Before IVF/ICSI
An observational study of Fibroid; Uterus Tumor, Complicating Pregnancy and Infertility, Female, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Studying the possible outcome differences between surgery or medical treatment with ulipristalacetate (UPA) solely before 'in-vitro fertilisation/intracytoplasmic sperm injection' (IVF/ICSI) treatment in infertile couples. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Fibroid; Uterus Tumor, Complicating Pregnancy, Infertility, Female, Surgical Procedure, Unspecified
- What is being tested?
- Ulipristal Acetate 5 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2016to 1 Jun 2026
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: females with fibroids and infertility
Who may be able to join
- 1st, 2nd or 3th IVF/ICSI attempt
- infertility Indications:
- unexplained
- tubal
- male/donor sperm
- endometriosis I/II
Show all 12Show fewer
- Body Mass Index (BMI) >18 - < 30
- Basal Follicle Stimulating Hormone (FSH) < 10 IU/L
- anti-mullerian hormone (AMH) > 1 ng/ml
- Normal ultrasound apart from the following:
- Type 2 fibroid : ≤2cm diameter
- Type 3 - 5 fibroids: with diameter ≥ 3 and ≤10cm according to classification of European Society for Gynecological Endoscopy (ESGE )
Who cannot join
- More than 2 submucous fibroids
- Poor responders
- Severe male factor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome.
Studying the possible outcome differences between surgery or medical treatment with ulipristalacetate (UPA) solely before 'in-vitro fertilisation/intracytoplasmic sperm injection' (IVF/ICSI) treatment in infertile couples.
Read the detailed description
Uterine fibroids are the most common benign uterine tumors in women of reproductive age. Symptoms are depending on size, number and localisation of the fibroids. Heavy menstrual bleeding, anaemia, abdominal pain, dyspareunia and urinary symptoms are often put forward.
Intramural and especially submucous myomas are known to decrease fertility and augment miscarriage rate. Some studies have demonstrated a negative effect of intramural fibroids on fertility outcome, while others do not. A recent meta-analysis found adverse pregnancy outcomes associated not only with submucous and intramural fibroids distorting the uterine cavity, but also with intramural fibroids not distorting the cavity.
Ulipristalacetate (Esmya®) is currently used to pre-treat symptomatic women with fibroids before surgical intervention. Esmya® has been demonstrated to be safe and effective in the treatment of fibroids. Due to apoptosis sometimes a reduction in volume of the myoma is seen. This effect could influence the fertility and operative outcome.
Current options are available before assisted reproductive technology (ART) for infertile women diagnosed with fibroids:
- no treatment
- medical pre-treatment before ART:
- with gonadotropin-releasing hormone (GnRH)-analogues followed by controlled ovarian stimulation
- with ESMYA followed by controlled ovarian stimulation
- surgical treatment after medical pre-treatment before ART:
- after pre-treatment with GnRH analogues followed by myomectomy
- after ESMYA followed by myomectomy
- surgical treatment without medical pre-treatment
In our tertiary infertility centre, at the discretion of the physician, as well ESMYA treatment solely or surgery before starting an IVF/ICSI treatment in women with intramural fibroids are often used. Is there a difference in ongoing pregnancy rate after IVF/ICSI in these patients?
Objective of the study Prospective and retrospective gathering of information regarding the efficacy of IVF/ICSI treatment (ongoing pregnancy rates) in patients undergoing medical or surgical treatment preceding their IVF/ICSI treatment in case of diagnosis of intramural fibroids. Especially ongoing pregnancy rates between patients receiving the ESMYA solely treatment and patients pre-treated by myomectomy before IVF/ICSI will be studied once sufficient data have been collected to deduce valuable study results.
- Conditions
- Fibroid; Uterus Tumor, Complicating Pregnancy, Infertility, Female, Surgical Procedure, Unspecified
- Being tested
- Ulipristal Acetate 5 MG Oral Tablet
- Keywords
- ulipristalacetate, fertility treatment, IVF/ICSI, fibroid
- Medical subject headings
- Leiomyoma, Uterine Neoplasms, Pregnancy Complications, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal Acetate 5 MG Oral TabletDrug
Also called surgery for fibroid
use of ulipristalacetate OR surgery before fertility treatment
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | patients treated by surgery before starting the IVF/ICSI treatment | |
| Ulipristalacetate group | patients treated by ulipristalacetate before starting IVF/ICSI treatment Receives: Drug: Ulipristal Acetate 5 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rates
Measured: 2 years
Secondary outcomes (3)
Miscarriage rate
Measured: 2 years
Time to pregnancy
years
Measured: 2 years
Obstetric outcome described as live birth
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid; Uterus Tumor, Complicating PregnancyStudies 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
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Cosyns, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028986
- Sponsor's protocol ID
- B.U.N.14320152
- Status last verified
- May 2023
- First submitted
- 15 Jul 2019
- Last updated
- 16 May 2023
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome.
- ClinicalTrials.gov ID
- NCT04028986
- Acronym / sponsor ID
- B.U.N.14320152
- Conditions
- Fibroid; Uterus Tumor, Complicating Pregnancy, Infertility, Female, Surgical Procedure, Unspecified
- Keywords
- ulipristalacetate, fertility treatment, IVF/ICSI, fibroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 Jul 2019 (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.
Studying the possible outcome differences between surgery or medical treatment with ulipristalacetate (UPA) solely before 'in-vitro fertilisation/intracytoplasmic sperm injection' (IVF/ICSI) treatment in infertile couples.
Detailed description
Uterine fibroids are the most common benign uterine tumors in women of reproductive age. Symptoms are depending on size, number and localisation of the fibroids. Heavy menstrual bleeding, anaemia, abdominal pain, dyspareunia and urinary symptoms are often put forward.
Intramural and especially submucous myomas are known to decrease fertility and augment miscarriage rate. Some studies have demonstrated a negative effect of intramural fibroids on fertility outcome, while others do not. A recent meta-analysis found adverse pregnancy outcomes associated not only with submucous and intramural fibroids distorting the uterine cavity, but also with intramural fibroids not distorting the cavity.
Ulipristalacetate (Esmya®) is currently used to pre-treat symptomatic women with fibroids before surgical intervention. Esmya® has been demonstrated to be safe and effective in the treatment of fibroids. Due to apoptosis sometimes a reduction in volume of the myoma is seen. This effect could influence the fertility and operative outcome.
Current options are available before assisted reproductive technology (ART) for infertile women diagnosed with fibroids:
- no treatment
- medical pre-treatment before ART:
- with gonadotropin-releasing hormone (GnRH)-analogues followed by controlled ovarian stimulation
- with ESMYA followed by controlled ovarian stimulation
- surgical treatment after medical pre-treatment before ART:
- after pre-treatment with GnRH analogues followed by myomectomy
- after ESMYA followed by myomectomy
- surgical treatment without medical pre-treatment
In our tertiary infertility centre, at the discretion of the physician, as well ESMYA treatment solely or surgery before starting an IVF/ICSI treatment in women with intramural fibroids are often used. Is there a difference in ongoing pregnancy rate after IVF/ICSI in these patients?
Objective of the study Prospective and retrospective gathering of information regarding the efficacy of IVF/ICSI treatment (ongoing pregnancy rates) in patients undergoing medical or surgical treatment preceding their IVF/ICSI treatment in case of diagnosis of intramural fibroids. Especially ongoing pregnancy rates between patients receiving the ESMYA solely treatment and patients pre-treated by myomectomy before IVF/ICSI will be studied once sufficient data have been collected to deduce valuable study results.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group | – | –patients treated by surgery before starting the IVF/ICSI treatment |
| Ulipristalacetate group | – | Drug: Ulipristal Acetate 5 MG Oral Tabletpatients treated by ulipristalacetate before starting IVF/ICSI treatment |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- females with fibroids and infertility
Key inclusion criteria (12 listed)
- 1st, 2nd or 3th IVF/ICSI attempt
- infertility Indications:
- Body Mass Index (BMI) >18 - < 30
- Basal Follicle Stimulating Hormone (FSH) < 10 IU/L
- anti-mullerian hormone (AMH) > 1 ng/ml
Key exclusion criteria (3 listed)
- More than 2 submucous fibroids
- Poor responders
- Severe male factor
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 Acetate 5 MG Oral TabletAlso: surgery for fibroiduse of ulipristalacetate OR surgery before fertility treatment | Drug | Ulipristalacetate group |
Primary outcome
ongoing pregnancy rates
Time frame: 2 years
3 secondary outcomes
Miscarriage rate
Time frame: 2 years
Time to pregnancy
Time frame: 2 years
Obstetric outcome described as live birth
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibroid; Uterus Tumor, Complicating Pregnancy and Infertility, Female, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 12 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2023. 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 Belgium. 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?
Results are not available in the source record.
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?
ongoing pregnancy rates (time frame: 2 years). 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 16 May 2023; AzTrials last refreshed its copy on 28 Oct 2026.