Role of Suppression of Endometriosis With Progestins Before IVF-ET

Study Overview
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Brief Summary
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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.

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

Conditions
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IVF, Endometriosis, Pregnancy Rate, Progestins, GnRH-analogue

Intervention / Treatment
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* Drug: Dienogest
* Drug: leuprorelin acetate


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dienogest<br> | Drug: Dienogest<br>* Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF<br>|
| Active Comparator: GnRH analogue<br> | Drug: leuprorelin acetate<br>* Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the fertilization rate | defined as the number of zygotes with two pronuclei divided by the number of oocytes | After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest) | 
| the number of transferrable embryos | defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation | After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest) | 
| the cost of the treatment | the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs | After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest) | 
| pregnancy rate per cycle started | defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment | After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest) | 
| the clinical pregnancy rate per cycle started | 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 | after women have postive pregnancy test (2 weeks after after the embryo transfer) | 
| the miscarriage rate | 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 | After occurence of the clinical pregnancy (5 months after after the embryo transfer) | 
| patient's quality of life | 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). | throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation through study completion, an average of 9 months |