Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
Overview
- Phase
- Not Applicable
- Intervention
- Dienogest 2 MG
- Conditions
- Endometriosis
- Sponsor
- Ospedale Policlinico San Martino
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
It is generally assumed that the major causes of in vitro fertilization (IVF) failure in women with endometriosis are diminished ovarian reserve, impaired endometrial receptivity and low quality of embryos. The use of prolonged courses of hormone therapy may play an important role in the strategy of overcoming endometriosis-related infertility. The aim of this study was to evaluate the use of dienogest (DNG) before an IVF cycle in women with endometriosis undergone a previous IVF failed cycle
Detailed Description
The primary outcomes of the study are clinical pregnancy rate and live birth rate after reaching 24 week's gestation. Secondary outcomes of the study are: changes in the diameter and volume of the largest endometrioma, total gonadotropin dose administered, number of mature oocytes collected, number of two-pronuclear (2PN) embryos, number of blastocysts.
Investigators
Fabio Barra
Principal Investigator
Ospedale Policlinico San Martino
Eligibility Criteria
Inclusion Criteria
- •diagnosis of endometriosis at magnetic resonance imaging or transvaginal ultrasonography;
- •one failed previous IVF cycle (including failure of frozen embryo transfer);
- •basal FSH \< 14.0 IU/L;
- •antimullerian hormone (AMH) blood level \>= 0.5 g/mL;
- •normal thyroid-stimulating hormone and prolactin.
Exclusion Criteria
- •history of surgery for endometriosis;
- •history of uterine or adnexal surgery;
- •use of hormonal therapies for the treatment of endometriosis related pain within 6 months before IVF;
- •adenomyosis (magnetic resonance imaging or transvaginal ultrasonography);
- •hydrosalpinx;
- •submucosal fibroids;
- •body mass index (BMI) ≥ 30 kg/m2;
- •severe male factor infertility (\< 5 million total motile sperm count).
Arms & Interventions
Patients pretreated with DNG
Patients having received a three-month treatment with DNG before undergoing IVF
Intervention: Dienogest 2 MG
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: 8 weeks
Live birth rate after reaching 24 week's gestation
Time Frame: 24 weeks
Secondary Outcomes
- Number of blastocysts.(During the procedure)
- Total gonadotropin dose administered(During the procedure)
- Number of two-pronuclear (2PN) embryos(During the procedure)
- Number of mature oocytes collected(During the procedure)