NCT04500743

Brief Summary

This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

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

August 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

July 29, 2020

Last Update Submit

August 3, 2020

Conditions

IVFEndometriosisPregnancy RateProgestinsGnRH-analogue

Outcome Measures

Primary Outcomes (1)

  • the number of retrieved oocytes

    the number of retrieved oocytes as the main concern was the effect of either GnRHa or Dienogest on ovarian responsiveness

    After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

Secondary Outcomes (7)

  • the fertilization rate

    After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

  • the number of transferrable embryos

    After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

  • the cost of the treatment

    After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

  • pregnancy rate per cycle started

    After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

  • the clinical pregnancy rate per cycle started

    after women have postive pregnancy test (2 weeks after after the embryo transfer)

  • +2 more secondary outcomes

Study Arms (2)

Dienogest

ACTIVE COMPARATOR
Drug: Dienogest

GnRH analogue

ACTIVE COMPARATOR
Drug: leuprorelin acetate

Interventions

DienogestDRUG

Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF

Dienogest
leuprorelin acetateDRUG

Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)

GnRH analogue

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • confirmed diagnosis of endometriosis
  • body mass index \< 35 Kg/m2

You may not qualify if:

  • if they have been already on long-term down-regulation of the pituitary gland with GnRHa for control of endometriosis
  • liver or kidney disease
  • evidence of diminished ovarian reserve (e.g. high FSH level \>12 IU/L or low AMH level \<1 ng/ml).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia Infertility research unit

Minya, Egypt

Location

Related Publications (2)

  • Chen I, Kives S, Zakhari A, Nguyen DB, Goldberg HR, Choudhry AJ, Le AL, Kowalczewski E, Schroll JB. Progestagens for pain symptoms associated with endometriosis. Cochrane Database Syst Rev. 2025 Oct 9;10(10):CD002122. doi: 10.1002/14651858.CD002122.pub3.

    PMID: 41065045DERIVED

  • Khalifa E, Mohammad H, Abdullah A, Abdel-Rasheed M, Khairy M, Hosni M. Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial. BMC Pregnancy Childbirth. 2021 Mar 30;21(1):264. doi: 10.1186/s12884-021-03736-2.

    PMID: 33784989DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

dienogestLeuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 5, 2020

Study Start

August 1, 2018

Primary Completion

October 31, 2019

Study Completion

April 30, 2020

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

EG(1)