Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial

National Research Centre, Egypt1 site in 1 country134 target enrollmentAugust 1, 2018

ConditionsIVF Endometriosis Pregnancy Rate Progestins GnRH-analogue

InterventionsDienogest leuprorelin acetate

DrugsDienogest leuprorelin acetate

Overview

Phase: Not Applicable
Intervention: Dienogest
Conditions: IVF
Sponsor: National Research Centre, Egypt
Enrollment: 134
Locations: 1
Primary Endpoint: the number of retrieved oocytes
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2018

End Date

April 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

National Research Centre, Egypt

Responsible Party

Principal Investigator

Mazen Abdel Rasheed

Principal Investigator

National Research Centre, Egypt

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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).

Arms & Interventions

Dienogest

Intervention: Dienogest

GnRH analogue

Intervention: leuprorelin acetate

Outcomes

Primary Outcomes

the number of retrieved oocytes

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

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

Secondary Outcomes

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))
the miscarriage rate(After occurence of the clinical pregnancy (5 months after after the embryo transfer))
patient's quality of life(throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation "through study completion, an average of 9 months")