NCT01779232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

2.8 years

First QC Date

January 28, 2013

Last Update Submit

April 25, 2016

Conditions

EndometriosisOvarian CystsInfertility

Keywords

endometriosisivfovarian reservedanazol

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    number of ongoing pregnancy for the number of IVF cycles

    12 months

Secondary Outcomes (1)

  • implantation rate

    12 months

Other Outcomes (1)

  • number of mature oocyte collected

    12 months

Study Arms (2)

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

DanazolDRUG

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

Also known as: Danatrol
danazol
placeboDRUG

administered daily like the active comparator

control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CERM

Rome, 00153, Italy

Location

MeSH Terms

Conditions

EndometriosisOvarian CystsInfertilityLong Qt Syndrome 3

Interventions

Danazol

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Marco Sbracia, MD

    Centre for Endocrinology and Reproductive Medicine, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

IT(1)