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Completed

NCT Number: NCT01779232

Danazol Treatment in Endometriosis Women Before IVF

The purpose of this study is to determine whether pre-treatment with danazol for at least 4 months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.

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Key information

Conditions

Endometriosis Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Long Qt Syndrome 3 Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CERM

Rome, 00153, Italy

About this study

Endometriosis is a chronic benign disease defined by the presence of endometrial tissue outside the uterine cavity, affecting women in their reproductive age. This disease is clinically characterized by infertility pelvic pain and the presence of ovarian cysts, endometriomas, and affects the about 10% of women. Women with endometriosis when undergo IVF show lower pregnancy rate than general population, and a reduced ovarian reserve, due to the diseases and often to ovarian surgery. The aim of this study is to evaluate if a pre-treatment with danazol, an anti-estrogenic agent, may improve the otcome of IVF cycles in these women

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of endometriosis previous laparoscopic surgery for ovarian endometriotic cysts infertility

Exclusion criteria

  • age more than 40 years systemic disease antimulleran hormone (AMH)<1 and FSH>20

Treatment and study plan

Danazol

Drug

100 mg day for 4 monthh in women with diagnosed endometriosis before IVF

Other names: Danatrol

Placebo

Drug

administered daily like the active comparator

Primary outcomes

  1. pregnancy rate

    Time frame: 12 months

    number of ongoing pregnancy for the number of IVF cycles

Secondary outcomes

  1. implantation rate

    Time frame: 12 months

    number of embryos implanted for the total number of embryos transferred

Other outcomes

  1. number of mature oocyte collected

    Time frame: 12 months

    number of mature oocyte collected for patient undergoing IVF

Sponsors and collaborators

Lead sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Network

Registry information

Official study title

Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2013
Registry last updated
Apr 27, 2016

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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