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Danazol Treatment in Endometriosis Women Before IVF

Primary Purpose

Endometriosis, Ovarian Cysts, Infertility

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Danazol

placebo

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, ivf, ovarian reserve, danazol

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

CERM

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control

danazol

Arm Description

patients treated with placebo for at least 4 months before IVF attempt

patients treated with danazol (100mg/day)for at least 4 months before IVF attempt

Outcomes

Primary Outcome Measures

pregnancy rate

number of ongoing pregnancy for the number of IVF cycles

Secondary Outcome Measures

implantation rate

number of embryos implanted for the total number of embryos transferred

Full Information

NCT ID

NCT01779232

First Posted

January 28, 2013

Last Updated

April 25, 2016

Sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

1. Study Identification

Unique Protocol Identification Number

NCT01779232

Brief Title

Danazol Treatment in Endometriosis Women Before IVF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis, Ovarian Cysts, Infertility

Keywords

endometriosis, ivf, ovarian reserve, danazol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

patients treated with placebo for at least 4 months before IVF attempt

Arm Title

danazol

Arm Type

Active Comparator

Arm Description

patients treated with danazol (100mg/day)for at least 4 months before IVF attempt

Intervention Type

Drug

Intervention Name(s)

Danazol

Other Intervention Name(s)

Danatrol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

administered daily like the active comparator

Primary Outcome Measure Information:

Title

pregnancy rate

Description

number of ongoing pregnancy for the number of IVF cycles

Time Frame

12 months

Secondary Outcome Measure Information:

Title

implantation rate

Description

number of embryos implanted for the total number of embryos transferred

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

number of mature oocyte collected

Description

number of mature oocyte collected for patient undergoing IVF

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Sbracia, MD

Organizational Affiliation

Centre for Endocrinology and Reproductive Medicine, Italy

Official's Role

Study Chair

Facility Information:

Facility Name

CERM

City

Rome

ZIP/Postal Code

00153

Country

Italy

12. IPD Sharing Statement

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Danazol Treatment in Endometriosis Women Before IVF

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