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Esmya Versus Surgery Before IVF/ICSI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04028986
Recruitment Status : Active, not recruiting
First Posted : July 23, 2019
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Stefan Cosyns, Universitair Ziekenhuis Brussel

Brief 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.

Condition or disease Intervention/treatment
Fibroid; Uterus Tumor, Complicating Pregnancy Infertility, Female Surgical Procedure, Unspecified Drug: Ulipristal Acetate 5 MG Oral Tablet

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:

  1. no treatment
  2. medical pre-treatment before ART:

    1. with gonadotropin-releasing hormone (GnRH)-analogues followed by controlled ovarian stimulation
    2. with ESMYA followed by controlled ovarian stimulation
  3. surgical treatment after medical pre-treatment before ART:

    1. after pre-treatment with GnRH analogues followed by myomectomy
    2. after ESMYA followed by myomectomy
  4. 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome.
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Surgery group
patients treated by surgery before starting the IVF/ICSI treatment
Ulipristalacetate group
patients treated by ulipristalacetate before starting IVF/ICSI treatment
Drug: Ulipristal Acetate 5 MG Oral Tablet
use of ulipristalacetate OR surgery before fertility treatment
Other Name: surgery for fibroid




Primary Outcome Measures :
  1. ongoing pregnancy rates [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Miscarriage rate [ Time Frame: 2 years ]
  2. Time to pregnancy [ Time Frame: 2 years ]
    years

  3. Obstetric outcome described as live birth [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
females with fibroids and infertility
Criteria

Inclusion Criteria:

  • 1st, 2nd or 3th IVF/ICSI attempt
  • infertility Indications:

    • unexplained
    • tubal
    • male/donor sperm
    • endometriosis I/II
  • 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 )

Exclusion Criteria:

  • More than 2 submucous fibroids
  • Poor responders
  • Severe male factor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028986


Locations
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Belgium
Universitair Ziekenhuis UZBrussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
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Responsible Party: Stefan Cosyns, Principal Investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04028986    
Other Study ID Numbers: B.U.N.14320152
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan Cosyns, Universitair Ziekenhuis Brussel:
ulipristalacetate
fertility treatment
IVF/ICSI
fibroid
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Infertility
Infertility, Female
Pregnancy Complications
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Ulipristal acetate
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female