NCT02575248

Brief Summary

This study aims at investigating the fertility outcome of endometriosis suppression with dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month in endometriosis patients stage I and II.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

September 5, 2015

Last Update Submit

June 20, 2017

Conditions

Infertility

Keywords

dienogestinfertilityendometriosis

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    fetal life detected by ultrasound

    2 months

Secondary Outcomes (1)

  • Ovulation rate

    up to 21 days

Study Arms (2)

Group A

EXPERIMENTAL

patients diagnosed laparoscopically with Endometriosis Stage 1 and Stage 2

Drug: Dienogest 2mgDrug: Clomiphene citrate 5 mg

group B

ACTIVE COMPARATOR

patients diagnosed laparoscopically with Endometriosis Stage 1 and Stage 2

Drug: Clomiphene citrate 5 mg

Interventions

Dienogest 2mgDRUG

Dienogest 2mg is given daily for 3 months then followed by Clomiphene citrate 5 mg induction of ovulation for three months

Group A
Clomiphene citrate 5 mgDRUG

Clomiphene citrate 5 mg for induction of ovulation for three months

Group Agroup B

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. All women recruited in this study will have the have- a definitive diagnosis of endometriosis grade I or grade II via laparoscopy just before randomization.

You may not qualify if:

  • Male factor.
  • Other factors e.g. mullerian duct anomalies, hydrosalpinx.
  • Age \> 35 years.
  • Day 3 FSH \> 14 mlu/ml or antimullerian hormone \<1 ng/1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShamsU

Abbasia, C, Egypt

RECRUITING

MeSH Terms

Conditions

InfertilityEndometriosis

Interventions

dienogestClomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • laila fareed, lecturer

    01222148471

    STUDY DIRECTOR

  • mostafa fouad, professor

    01226188993

    STUDY DIRECTOR

Central Study Contacts

sherif Abdelhamid, professor

CONTACT

01001424742

Noha rabei, professor

CONTACT

01227174996

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 5, 2015

First Posted

October 14, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Locations

EG(1)