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Completed

NCT Number: NCT04306276

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

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

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Key information

Conditions

Endometriosis Endometriosis Ovary Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female IVF Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dienogest 2 MG

Drug

Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 8 weeks

  2. Live birth rate after reaching 24 week's gestation

    Time frame: 24 weeks

Secondary outcomes

  1. Total gonadotropin dose administered

    Time frame: During the procedure

  2. Number of mature oocytes collected

    Time frame: During the procedure

  3. Number of two-pronuclear (2PN) embryos

    Time frame: During the procedure

  4. Number of blastocysts.

    Time frame: During the procedure

Sponsors and collaborators

Lead sponsor

Ospedale Policlinico San Martino

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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