Danazol Treatment in Endometriosis Women Before IVF

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01779232

Enrollment

150

Registered

2013-01-30

Start date

2012-10-31

Completion date

2015-09-30

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Infertility, Ovarian Cysts

Keywords

endometriosis, ivf, ovarian reserve, danazol

Brief summary

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.

Detailed description

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

Interventions

DRUGDanazol

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

DRUGplacebo

administered daily like the active comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
pregnancy rate	12 months	number of ongoing pregnancy for the number of IVF cycles

Secondary

Measure	Time frame	Description
implantation rate	12 months	number of embryos implanted for the total number of embryos transferred

Other

Measure	Time frame	Description
number of mature oocyte collected	12 months	number of mature oocyte collected for patient undergoing IVF

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026