SterilityNCT03173404
Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection
A study testing Hysteroscopy in people with Sterility, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
This is a prospective randomized open-label trial. Women scheduled for their first or second in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Sterility
- What is being tested?
- Hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2014to Jan 2017
- Phase
- Interventional
- 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
Who may be able to join
- Women with infertility / primary infertility.
- Women who are about to start an IVF/ICSI cycle with their own eggs.
- Age greater than or equal to 18 years and less than or equal to 40 years.
- Women in whom a multiple follicular development will be developed with a short protocol with antagonists or long with agonists, and starting dose of gonadotropins according to clinical criteria.
- Women with uterine ultrasound without endometrial pathology
Who cannot join
- Ovarian reserve: Antimullerian hormone <0.5 ng / dl or Count of antral follicles <5 between both ovaries.
- Myomatous uterus: presence of> 2 myomas> 4cm or that deform uterine cavity.
- Uterine malformations.
- Body mass index (BMI) <18 or> 30.
- Polycystic ovarian syndrome: according to European Society of Human Reproduction and Embryology (ESRHE)/Rotterdam 2003 criteria.
- Moderate-severe endometriosis.
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- Background or presence of pelvic inflammatory disease.
- Hydrosalpinx not excised or occluded.
- Hyperprolactinemia, defined as prolactin levels greater than 50 ng / ml.
- Diagnostic history of endometrial hyperplasia.
- Severe male factor: severe oligoasthenoteratozoospermia with a sperm cell count (REM) <100,000 spermatozoa / ml.
- Impossibility to apply the treatments provided by the study in the terms established by the protocol.
- Contraindication for the use of any of the treatments provided in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective randomized open-label trial. Women scheduled for their first or second in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy
Read the detailed description
This is a prospective randomized open-label trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy. Then IVF cycle was performed with habitual protocol. Beta Corionic Gonatropic hormone (BhCG) test two weeks after embryo transfer was done. If test was positive, patients were followed up for detection pregnancy by transvaginal ultrasound two weeks later. Another transvaginal ultrasound at 12 weeks of gestation was done to confirm ongoing pregnancy. Biochemical pregnancy, implantation, on-going pregnancy and livebirth rates were compared in both groups.
Miscarriage, complications rate and hysteroscopy tolerability were also analyzed.
- Conditions
- Sterility
- Being tested
- Hysteroscopy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyProcedure or surgery
The hysteroscopy is the visualization of the cervical canal and uterine cavity with a camera. Patients randomized to group I underwent hysteroscopy prior to the IVF cycle.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients underwent hysteroscopy examination before IVF cycle. Receives: Procedure: Hysteroscopy |
| Group II | No intervention | Patients underwent direct IVF cycle without previous hysteroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment
Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment comparing both groups.
Measured: 12 months
Secondary outcomes (3)
Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies.
Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies in the rate of pregnancy and livebirth.
Measured: 12 months
Rate of hysteroscopy tolerance
The tolerance of the procedure was evaluate in the patients randomized to the group I of the study.
Measured: 1 month.
Hysteroscopy complication rate.
We evaluate the complication of the hysteroscopy during and after the procedure. Includes blooding, infections, uterine perforation, etc.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jul 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SterilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized open-label clinical trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I): 31 patients underwent hysteroscopy examination before IVF cycle. The second group (group II): 37 patients underwent direct cycle without previous hysteroscopy.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173404
- Sponsor's protocol ID
- 3913
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT03173404
- Acronym / sponsor ID
- 3913
- Conditions
- Sterility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Jun 2017 (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.
This is a prospective randomized open-label trial. Women scheduled for their first or second in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy
Detailed description
This is a prospective randomized open-label trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy. Then IVF cycle was performed with habitual protocol. Beta Corionic Gonatropic hormone (BhCG) test two weeks after embryo transfer was done. If test was positive, patients were followed up for detection pregnancy by transvaginal ultrasound two weeks later. Another transvaginal ultrasound at 12 weeks of gestation was done to confirm ongoing pregnancy. Biochemical pregnancy, implantation, on-going pregnancy and livebirth rates were compared in both groups.
Miscarriage, complications rate and hysteroscopy tolerability were also analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open-label clinical trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I): 31 patients underwent hysteroscopy examination before IVF cycle. The second group (group II): 37 patients underwent direct cycle without previous hysteroscopy.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: HysteroscopyPatients underwent hysteroscopy examination before IVF cycle. |
| Group II | No intervention | –Patients underwent direct IVF cycle without previous hysteroscopy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with infertility / primary infertility.
- Women who are about to start an IVF/ICSI cycle with their own eggs.
- Age greater than or equal to 18 years and less than or equal to 40 years.
- Women in whom a multiple follicular development will be developed with a short protocol with antagonists or long with agonists, and starting dose of gonadotropins according to clinical criteria.
- Women with uterine ultrasound without endometrial pathology
Key exclusion criteria (13 listed)
- Ovarian reserve: Antimullerian hormone <0.5 ng / dl or Count of antral follicles <5 between both ovaries.
- Myomatous uterus: presence of> 2 myomas> 4cm or that deform uterine cavity.
- Uterine malformations.
- Body mass index (BMI) <18 or> 30.
- Polycystic ovarian syndrome: according to European Society of Human Reproduction and Embryology (ESRHE)/Rotterdam 2003 criteria.
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 |
|---|---|---|
| HysteroscopyThe hysteroscopy is the visualization of the cervical canal and uterine cavity with a camera. Patients randomized to group I underwent hysteroscopy prior to the IVF cycle. | Procedure or surgery | Group I |
Primary outcome
Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment
Time frame: 12 months
Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment comparing both groups.
3 secondary outcomes
Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies.
Time frame: 12 months
Rate of hysteroscopy tolerance
Time frame: 1 month.
Hysteroscopy complication rate.
Time frame: 2 months
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 1 Jun 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy in people with Sterility, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 13 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 1 Jun 2017. 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 Spain. 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?
Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment (time frame: 12 months). 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 1 Jun 2017.