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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Clinical pregnancy rate

Timeframe: 8 weeks

Live birth rate after reaching 24 week's gestation

Timeframe: 24 weeks

Trial details

NCT IDNCT04306276

SponsorOspedale Policlinico San Martino

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-03-01

View on ClinicalTrials.gov More Endometriosis trials