Danazol Treatment in Endometriosis Women Before IVF | NCT01779232

Studies
Danazol Treatment in Endometriosis Women Before IVF

NCT01779232

Sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Status

Completed

Last Update Posted

Apr 27, 2016Estimated

Enrollment

150Actual

Phase

Phase 4

Conditions

Endometriosis
Ovarian Cysts
Infertility

Interventions

Danazol
placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Aug 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2016

Last Update Posted Date

Apr 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fabio Scarpellini, Investigator, Centre for Endocrinology and Reproductive Medicine, ItalyPrincipal Investigator

Lead Sponsor

Centre for Endocrinology and Reproductive Medicine, ItalyNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	Placebo Comparator	patients treated with placebo for at least 4 months before IVF attempt	Drug: placebo
danazol	Active Comparator	patients treated with danazol (100mg/day)for at least 4 months before IVF attempt	Drug: Danazol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Danazol	Drug	100 mg day for 4 monthh in women with diagnosed endometriosis before IVF	danazol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Sbracia, MD	Centre for Endocrinology and Reproductive Medicine, Italy	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CERM		Rome		00153	Italy

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis
D010048	Ovarian Cysts
D007246	Infertility
C565840	Long Qt Syndrome 3

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003613	Danazol

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided