Role of Suppression of Endometriosis With Progestins Before IVF-ET

Not Applicable

Completed

• Conditions: IVF; Endometriosis; Pregnancy Rate; Progestins; GnRH-analogue
• Interventions: Drug: leuprorelin acetate; Drug: Dienogest

• Registration Number: NCT04500743
• Lead Sponsor: National Research Centre, Egypt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-10-31
• Study Completion: 2020-04-30
• Study First Submitted: 2020-07-29
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-03
• Last Update Submitted: 2020-08-03
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH analogue	leuprorelin acetate	-
Dienogest	Dienogest	-

Primary Outcome Measures

Name	Time	Method
the number of retrieved oocytes	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 Outcome Measures

Name	Time	Method
the fertilization rate	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)	defined as the number of zygotes with two pronuclei divided by the number of oocytes
the number of transferrable embryos	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)	defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation
the cost of the treatment	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)	the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs
pregnancy rate per cycle started	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)	defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment
the clinical pregnancy rate per cycle started	after women have postive pregnancy test (2 weeks after after the embryo transfer)	defined as the number of patients with at least one intrauterine gestational sac with identifiable fetal heart pulsations over the total number of patients starting the treatment
the miscarriage rate	After occurence of the clinical pregnancy (5 months after after the embryo transfer)	defined as patients with identified intrauterine gestational sac without a fetal pole, or a fetal pole with no heart pulsations with no other viable fetuses over the number of patients with positive pregnancy test
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"	patient's quality of life during the pretreatment period as assessed by the Fertility quality of life (FertiQoL) questionnaire with a range of 0 (the worst) to 100 (the best).

Trial Locations

Locations (1)

Minia Infertility research unit; 🇪🇬 Minya, Egypt