IVF, Endometriosis, Pregnancy Rate, Progestins, GnRH-analogue
Conditions
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.
Interventions
DRUGDienogest
Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF
DRUGleuprorelin acetate
Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)
Sponsors
National Research Centre, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 40 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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). |
| 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 |
Countries
Egypt
Outcome results
None listed