Pre-Implantation Embryo RecoveryNCT02676479
Uterine Irrigation Method in Infertility Patients Who Require PGD
A study testing Uterine Lavage Group in people with Pre-Implantation Embryo Recovery and Genetic Diseases, Inborn, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women only
- Conditions the study is for
- Pre-Implantation Embryo Recovery, Genetic Diseases, Inborn
- What is being tested?
- Uterine Lavage Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2016to Dec 2016
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal Female Age 21-39 years old.
- BMI between 18-35 kg/m2
- Presence of a normal uterine cavity, both fallopian tubes and their respective ovaries as assessed by hysterosalpingogram and/or sonohysterogram (SHG).
- Regular menstrual cycles every 26-32 days
- Male partner aged 21-40 yrs with a normal semen analysis.
- Infertile couples, which carry hereditary genetic diseases and genetic anomalies, and have a high probability of passing these on to their children.
Who cannot join
- Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator
- Previous history of prior appendectomy and/or lower abdominal surgery
- Previous history of prior tubal surgery or ectopic pregnancy
- Contraindication for the use of oral contraceptive pills
- Clinically significant abnormal basic metabolic panel lab results
- Positive test or history of any of the following conditions:
Show all 14Show fewer
- Human immunodeficiency virus (HIV)
- Hepatitis B infection
- Hepatitis C infection
- Syphilis (RPR)
- Chlamydial pelvic infection
- Gonorrheal pelvic infection.
- Positive Pregnancy Test
- No prior IUD for 60 days and not currently in place
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University School of Medicine
Istanbul, 34093
About this study
Official title: The Histological and Genetic Investigation of Cells, Fluid and Tissue in the Uterine Cavity, Using the Uterine Irrigation Method, in Patients Who Suffer From Unexplained Infertility and Hereditary Genetic Disease, and Who Require PGD Scans.
The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene. The female partner will be superovulated to mature multiple oocytes which can be fertilized, inseminated with her partner's sperm through intra-uterine insemination (IUI). Four to six days after IUI, the female partner will undergo a non-surgical uterine lavage procedure to recover preimplantation embryos.
Read the detailed description
The study is a prospective, single center, single-arm study to evaluate healthy cells which do not carry illnesses, by collecting and performing the histological and genetic analyses of blastocysts, endometrial tissue and cells, which have been formed in the uterus, without any burden of the morbidity and mortality caused by the oocyte collection process, and which thereby have not been subjected to any iatrogenic intervention, with uterine lavage.
The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene.
The female partner will be superovulated to mature multiple oocytes which can be fertilized, inseminated with her partner's sperm through intra-uterine insemination (IUI). Four to six days after IUI, the female partner will undergo a non-surgical uterine lavage procedure to recover preimplantation embryos.
Following lavage, a GnRH antagonist will be administered to cause lysis of multiple corpora lutea to mitigate risk of hyperstimulation from the use of fertility medication and reduce the risk of ectopic pregnancy should the lavage procedure not recover all preimplantation embryos.
Recovered preimplantation embryos may be screened for aneuploidy and genetic disease, then cryopreserved for potential future use by the subjects and the Investigator separate from the purpose of this study.
Each subject participates in the trial for up to 10-20 weeks.
- Being tested
- Uterine Lavage Group
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Lavage GroupDevice
The PI places the Lavage Catheter per instructions for use
- Use of a tenaculum or cervical stitch is required
- Use of saline to wash the cervix is required
- Use of abdominal ultrasound guidance with a full bladder is required The PI records if there was clinically significant fluid loss through the cervix.
| Study group | Role | What they receive |
|---|---|---|
| Uterine Lavage Group | Experimental | The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene.
The female partner will be superovulated to mature multiple oocytes which can be fertilized, inseminated with her partner's sperm through intra-uterine insemination (IUI). Four to six days after IUI, the female partner will undergo a non-surgical uterine lavage procedure (Previvo Uterine Lavage System™, CA, U.S.A.) to recover preimplantation embryos. Receives: Device: Uterine Lavage Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst Retrieval
Number of blastocyst retrieved
Measured: 3 months
Secondary outcomes (1)
Blastocyst Quality
Number of cells developed in each blastocyst
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Implantation Embryo RecoveryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Previvo Genetics, Acibadem Fulya Hospital
- Responsible party
- Principal investigator, Ercan Bastu, Istanbul University
- Investigators
- Ercan Bastu, MD,AssocProf, Principal investigator, Istanbul University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676479
- Sponsor's protocol ID
- 2016
- Status last verified
- May 2016
- First submitted
- 23 Jan 2016
- Last updated
- 1 Jun 2016
- 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 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Histological and Genetic Investigation of Cells, Fluid and Tissue in the Uterine Cavity, Using the Uterine Irrigation Method, in Patients Who Suffer From Unexplained Infertility and Hereditary Genetic Disease, and Who Require PGD Scans.
- ClinicalTrials.gov ID
- NCT02676479
- Acronym / sponsor ID
- 2016
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Previvo Genetics, Acibadem Fulya Hospital
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Feb 2016 (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.
The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene. The female partner will be superovulated to mature multiple oocytes which can be fertilized, inseminated with her partner's sperm through intra-uterine insemination (IUI). Four to six days after IUI, the female partner will undergo a non-surgical uterine lavage procedure to recover preimplantation embryos.
Detailed description
The study is a prospective, single center, single-arm study to evaluate healthy cells which do not carry illnesses, by collecting and performing the histological and genetic analyses of blastocysts, endometrial tissue and cells, which have been formed in the uterus, without any burden of the morbidity and mortality caused by the oocyte collection process, and which thereby have not been subjected to any iatrogenic intervention, with uterine lavage.
The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene.
The female partner will be superovulated to mature multiple oocytes which can be fertilized, inseminated with her partner's sperm through intra-uterine insemination (IUI). Four to six days after IUI, the female partner will undergo a non-surgical uterine lavage procedure to recover preimplantation embryos.
Following lavage, a GnRH antagonist will be administered to cause lysis of multiple corpora lutea to mitigate risk of hyperstimulation from the use of fertility medication and reduce the risk of ectopic pregnancy should the lavage procedure not recover all preimplantation embryos.
Recovered preimplantation embryos may be screened for aneuploidy and genetic disease, then cryopreserved for potential future use by the subjects and the Investigator separate from the purpose of this study.
Each subject participates in the trial for up to 10-20 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterine Lavage Group | Experimental | Device: Uterine Lavage GroupThe study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene. The female partner will be superovulated to mature multiple oocytes which can be fertilized, inseminated with her partner's sperm through intra-uterine insemination (IUI). Four to six days after IUI, the female partner will undergo a non-surgical uterine lavage procedure (Previvo Uterine Lavage System™, CA, U.S.A.) to recover preimplantation embryos. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Premenopausal Female Age 21-39 years old.
- BMI between 18-35 kg/m2
- Presence of a normal uterine cavity, both fallopian tubes and their respective ovaries as assessed by hysterosalpingogram and/or sonohysterogram (SHG).
- Regular menstrual cycles every 26-32 days
- Male partner aged 21-40 yrs with a normal semen analysis.
Key exclusion criteria (14 listed)
- Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator
- Previous history of prior appendectomy and/or lower abdominal surgery
- Previous history of prior tubal surgery or ectopic pregnancy
- Contraindication for the use of oral contraceptive pills
- Clinically significant abnormal basic metabolic panel lab results
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 |
|---|---|---|
| Uterine Lavage GroupThe PI places the Lavage Catheter per instructions for use * Use of a tenaculum or cervical stitch is required * Use of saline to wash the cervix is required * Use of abdominal ultrasound guidance with a full bladder is required The PI records if there was clinically significant fluid loss through the cervix. | Device | Uterine Lavage Group |
Primary outcome
Blastocyst Retrieval
Time frame: 3 months
Number of blastocyst retrieved
1 secondary outcome
Blastocyst Quality
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Individual participant dataSharing planned: No
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.
Ercan Bastu, MD,AssocProf principal investigator
Istanbul University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Lavage Group in people with Pre-Implantation Embryo Recovery and Genetic Diseases, Inborn, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 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: status not confirmed, as of the sponsor's last update on 1 Jun 2016. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Blastocyst Retrieval (time frame: 3 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 2016.