EndometriosisNCT04306276
Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
An observational study of Endometriosis and Endometriosis Ovary, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis Ovary, IVF
- What is being tested?
- Dienogest 2 MG
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with endometriosis who previously failed one IVF cycle and all resultant frozen embryo transfer
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Endometriosis, Endometriosis Ovary, IVF
- Being tested
- Dienogest 2 MG
- Keywords
- endometriosis, IVF
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest 2 MGDrug
Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing direct IVF | Patients directly undergo IVF without receiving previous hormonal treatment | |
| Patients pretreated with DNG | Patients having received a three-month treatment with DNG before undergoing IVF Receives: Drug: Dienogest 2 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 8 weeks
Live birth rate after reaching 24 week's gestation
Measured: 24 weeks
Secondary outcomes (4)
Total gonadotropin dose administered
Measured: During the procedure
Number of mature oocytes collected
Measured: During the procedure
Number of two-pronuclear (2PN) embryos
Measured: During the procedure
Number of blastocysts.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Jan 2020
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Barra, Ospedale Policlinico San Martino
- Investigators
- Fabio Barra, MD, PhD, Principal investigator, IRCCS Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306276
- Sponsor's protocol ID
- DIENIVF-ENDO
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
- ClinicalTrials.gov ID
- NCT04306276
- Acronym / sponsor ID
- DIENIVF-ENDO
- Conditions
- Endometriosis, Endometriosis Ovary, IVF
- Keywords
- endometriosis, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing direct IVF | – | –Patients directly undergo IVF without receiving previous hormonal treatment |
| Patients pretreated with DNG | – | Drug: Dienogest 2 MGPatients having received a three-month treatment with DNG before undergoing IVF |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with endometriosis who previously failed one IVF cycle and all resultant frozen embryo transfer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dienogest 2 MGThree-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF | Drug | Patients pretreated with DNG |
Primary outcome
Clinical pregnancy rate
Time frame: 8 weeks
Live birth rate after reaching 24 week's gestation
Time frame: 24 weeks
4 secondary outcomes
Total gonadotropin dose administered
Time frame: During the procedure
Number of mature oocytes collected
Time frame: During the procedure
Number of two-pronuclear (2PN) embryos
Time frame: During the procedure
Number of blastocysts.
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Barra, MD, PhD principal investigator
IRCCS Ospedale Policlinico San Martino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Endometriosis Ovary, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.