Esmya Versus Surgery Before IVF/ICSI

May 15, 2023 updated by: Stefan Cosyns, Universitair Ziekenhuis Brussel

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • Universitair Ziekenhuis UZBrussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

females with fibroids and infertility

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • surgery for fibroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ongoing pregnancy rates
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage rate
Time Frame: 2 years
2 years
Time to pregnancy
Time Frame: 2 years
years
2 years
Obstetric outcome described as live birth
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.U.N.14320152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility, Female

Clinical Trials on Ulipristal Acetate 5 MG Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe