Role of Suppression of Endometriosis With Progestins Before IVF-ET
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dienogest
|
Drug: Dienogest
Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF
|
| Active Comparator: GnRH analogue
|
Drug: leuprorelin acetate
Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Minia Infertility research unit | Minya | Egypt |
Sponsors and Collaborators
- National Research Centre, Egypt
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Dienogest before IVF