Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a… (NCT04306276) | Clinical Trial Compass
CompletedNot Applicable
Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
Italy140 participantsStarted 2020-01-01
Plain-language 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
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at using dienogest as a pretreatment before IVF in women with endometriosis who had already failed at least one IVF cycle — does my situation match that profile closely enough that this approach might be worth discussing for me?
2Since this trial has already completed, has my doctor seen the results, and do those results suggest that pretreatment with dienogest actually improved clinical pregnancy or live birth rates compared to not using it?
3Dienogest is a hormone therapy that suppresses endometriosis, but it also delays starting the IVF process — given my age and ovarian reserve, would that delay potentially affect my chances more than the potential benefit of suppressing my endometriosis first?
4Since this trial specifically focused on women with endometriosis affecting the ovaries, and depending on where my endometriosis is located, does my doctor think this pretreatment strategy would be relevant to my specific case?
5Are there other completed or ongoing trials, or established protocols, that my doctor would compare this dienogest pretreatment approach against before recommending it as part of my IVF plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical pregnancy rate
Timeframe: 8 weeks
2
Live birth rate after reaching 24 week's gestation