SubfertilityNCT01842178
Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation
A study testing scratching in people with Subfertility, run by Centro de Infertilidad y Reproducción Humana at 1 site in Spain.
Trial summary
This study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- scratching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to 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 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Do IVF cycle with donor eggs
- Will adjust to protocol for the study.
- Have signed informed consent
Who cannot join
- Clinically significant systemic disease, hypothalamic or pituitary tumors
- ovarian, uterine or breast cancer
- hormonal abnormalities and / or medical , biochemistry, hematology pathology, which might interfere with gonadotropin treatment.
- known positivity for human immunodeficiency virus (HIV), hepatitis C or B virus (HCV / HBV) of the candidate or her partner.
- Uterine Factor(submucosal fibroids, intramural fibroids> 4 cm)
- Hydrosalpinx
Show all 14Show fewer
- Patients receiving immune treatment
- Positive Diagnosis Thrombophilia
- preimplantation genetic diagnosis needed
- In case of using marital sperm are excluded the following patients:Altered male karyotype, Altered Meiosis in testicular biopsy, Altered FISH, sperm Fragmentation> 45%
- Pregnancy contraindication
- Known allergy to preparations containing estrogens or any of its excipients.
- Simultaneous participation in another clinical trial with medication.
- Do not want or can not adjust to study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation
This study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes.
Read the detailed description
This is a randomized, comparative, prospective, double Blind study.
The First stage of this study consists of revising the patients medical records to identify possible candidates. Patients indicated are randomized into two groups: experimental and control. They are followed up to 12 week of pregnancy.
- Conditions
- Subfertility
- Being tested
- scratching
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scratchingProcedure or surgery
Also called endometrial enjury
Endometrial Injury
- Done between 18-24 days prior to embryo transfer cycle.
- Using transfer catheter.
- Introduction of the same to the uterine fundus.
- Systematic scrapping of the four uterine walls, lengthwise.
- Performed by a skilled doctor.
- Subsequent ultrasound control.
| Study group | Role | What they receive |
|---|---|---|
| scratching | Experimental | Patients will have an endometrial injury done on purpose, between 18-24 days prior to IVF cycle with a transfer catheter on the surgery outpatient department.
Endometrial Injury
* Done between 18-24 days prior to embryo transfer cycle.
* Using transfer catheter.
* Introduction of the same to the uterine fundus.
* Systematic scrapping of the four uterine walls, lengthwise.
* Performed by a skilled doctor.
* Subsequent ultrasound control Receives: Procedure: scratching |
| scratching simulation | Placebo comparator | Patients will come to control visit between day 18-24. A scratching simulation will be done. Receives: Procedure: scratching |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical pregnancy
Determination of human chorionic gonadotropin blood levels.
Measured: 14-16 days post-follicular punction
Secondary outcomes (1)
Clinical pregnancy
Ultrasound
Measured: 6 pregnancy weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: Principal investigator retired from the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Infertilidad y Reproducción Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- miguel angel checa, MD, Study director, Centro de Infertilidad y Reproducción Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842178
- Sponsor's protocol ID
- CIRH-OLE:2013
- Status last verified
- May 2017
- First submitted
- 25 Apr 2013
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation
- ClinicalTrials.gov ID
- NCT01842178
- Acronym / sponsor ID
- CIRH-OLE:2013
- Conditions
- Subfertility
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator retired from the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centro de Infertilidad y Reproducción HumanaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 29 Apr 2013 (estimated)
- 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 study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes.
Detailed description
This is a randomized, comparative, prospective, double Blind study.
The First stage of this study consists of revising the patients medical records to identify possible candidates. Patients indicated are randomized into two groups: experimental and control. They are followed up to 12 week of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scratching | Experimental | Procedure: scratchingPatients will have an endometrial injury done on purpose, between 18-24 days prior to IVF cycle with a transfer catheter on the surgery outpatient department. Endometrial Injury * Done between 18-24 days prior to embryo transfer cycle. * Using transfer catheter. * Introduction of the same to the uterine fundus. * Systematic scrapping of the four uterine walls, lengthwise. * Performed by a skilled doctor. * Subsequent ultrasound control |
| scratching simulation | Placebo comparator | Procedure: scratchingPatients will come to control visit between day 18-24. A scratching simulation will be done. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Do IVF cycle with donor eggs
- Will adjust to protocol for the study.
- Have signed informed consent
Key exclusion criteria (14 listed)
- Clinically significant systemic disease, hypothalamic or pituitary tumors
- ovarian, uterine or breast cancer
- hormonal abnormalities and / or medical , biochemistry, hematology pathology, which might interfere with gonadotropin treatment.
- known positivity for human immunodeficiency virus (HIV), hepatitis C or B virus (HCV / HBV) of the candidate or her partner.
- Uterine Factor(submucosal fibroids, intramural fibroids> 4 cm)
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 |
|---|---|---|
| scratchingAlso: endometrial enjuryEndometrial Injury * Done between 18-24 days prior to embryo transfer cycle. * Using transfer catheter. * Introduction of the same to the uterine fundus. * Systematic scrapping of the four uterine walls, lengthwise. * Performed by a skilled doctor. * Subsequent ultrasound control. | Procedure or surgery | scratching, scratching simulation |
Primary outcome
biochemical pregnancy
Time frame: 14-16 days post-follicular punction
Determination of human chorionic gonadotropin blood levels.
1 secondary outcome
Clinical pregnancy
Time frame: 6 pregnancy weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: No
Related trials for Subfertility
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Not yet recruitingPhase 3
Progesterone Luteal Support in Unexplained Infertility Management
Infertility, Female Infertility
RecruitingObservational study
Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters
Male Infertility, Male Subfertility
RecruitingPhase 3
GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET
Subfertility
RecruitingObservational study
The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI
Endometritis; Chronic, Subfertility
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.
miguel angel checa, MD study director
Centro de Infertilidad y Reproducción Humana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scratching in people with Subfertility, run by Centro de Infertilidad y Reproducción Humana 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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 10 May 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
biochemical pregnancy (time frame: 14-16 days post-follicular punction). 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 10 May 2017.