Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle

March 10, 2020 updated by: Fabio Barra, Ospedale Policlinico San Martino
It is generally assumed that the major causes of in vitro fertilization (IVF) failure in women with endometriosis are diminished ovarian reserve, impaired endometrial receptivity and low quality of embryos. The use of prolonged courses of hormone therapy may play an important role in the strategy of overcoming endometriosis-related infertility. The aim of this study was to evaluate the use of dienogest (DNG) before an IVF cycle in women with endometriosis undergone a previous IVF failed cycle

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary outcomes of the study are clinical pregnancy rate and live birth rate after reaching 24 week's gestation.

Secondary outcomes of the study are: changes in the diameter and volume of the largest endometrioma, total gonadotropin dose administered, number of mature oocytes collected, number of two-pronuclear (2PN) embryos, number of blastocysts.

Study Type

Observational

Enrollment (Actual)

140

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

  • Italy
      • Genoa, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino

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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with endometriosis who previously failed one IVF cycle and all resultant frozen embryo transfer

Description

Inclusion Criteria:

  • diagnosis of endometriosis at magnetic resonance imaging or transvaginal ultrasonography;
  • one failed previous IVF cycle (including failure of frozen embryo transfer);
  • basal FSH < 14.0 IU/L;
  • antimullerian hormone (AMH) blood level >= 0.5 g/mL;
  • normal thyroid-stimulating hormone and prolactin.

Exclusion Criteria:

  • history of surgery for endometriosis;
  • history of uterine or adnexal surgery;
  • use of hormonal therapies for the treatment of endometriosis related pain within 6 months before IVF;
  • adenomyosis (magnetic resonance imaging or transvaginal ultrasonography);
  • hydrosalpinx;
  • submucosal fibroids;
  • body mass index (BMI) ≥ 30 kg/m2;
  • severe male factor infertility (< 5 million total motile sperm count).

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing direct IVF
Patients directly undergo IVF without receiving previous hormonal treatment
Patients pretreated with DNG
Patients having received a three-month treatment with DNG before undergoing IVF
Drug: Dienogest 2 MG
Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 8 weeks
8 weeks
Live birth rate after reaching 24 week's gestation
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Total gonadotropin dose administered
Time Frame: During the procedure
During the procedure
Number of mature oocytes collected
Time Frame: During the procedure
During the procedure
Number of two-pronuclear (2PN) embryos
Time Frame: During the procedure
During the procedure
Number of blastocysts.
Time Frame: During the procedure
During the procedure

Collaborators and Investigators

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

Sponsor

Ospedale Policlinico San Martino

Investigators

  • Principal Investigator: Fabio Barra, MD, PhD, IRCCS Ospedale Policlinico San Martino

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, 2020

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

March 8, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIENIVF-ENDO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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.

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