Female InfertilityNCT02640261
Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.
An observational study of Female Infertility, run by Centro di Procreazione Assistita Demetra at 1 site in Italy.
Trial summary
The objective of our observational prospective study will be to compare, for women treated for infertility and included in a ICSI program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Female Infertility
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Apr 2018
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Normogonadotropic Infertile Women that failed the first IVFcycle and require r-hLh add on therapy as per Demetra clinical standard procedures
Who may be able to join
- women age from < 38 years
- normal body mass index (BMI ) from 18 to 26
- parameters for ovarian reserve in the normal range (day 3 FSH levels < 10 mUI/ml ; day 3 E2 levels < 80 pg/ml; anti-mullerian hormone (AMH) levels > 1.5 ng/ml ; AFC (antral follicular count) > 6 )
Who cannot join
- polycystic ovary syndrome (PCOS)
- ovarian surgery
- pelvic endometriosis
- POR according to ESHRE criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
DEMETRA
Florence, Italy, 50129
Cristiana Barbosa, MD, 00393478838377, quartim.barbosa@centrodemetra.com
About this study
The objective of our observational prospective study will be to compare, for women treated for infertility and included in a ICSI program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other group on the basis of both embryo morphology and follicular fluid cytokines content.
100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who have had a low ovarian response, Fort < 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH , according to the standard established by our clinical practice.
Read more
Patients will be part of one of the following groups:
Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.
- Conditions
- Female Infertility
- Keywords
- r-hLH, Cytokines, Follicular Fluid
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Single embryo transfer on day 5, according to standard embryo morphological criteria | |
| Group 2 | Single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Measured: 2 years
Secondary outcomes (1)
Delivery Rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Procreazione Assistita Demetra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabetta Chelo, MD, Principal investigator, Clinica Center DEMETRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640261
- Sponsor's protocol ID
- Echelo
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.
- ClinicalTrials.gov ID
- NCT02640261
- Acronym / sponsor ID
- Echelo
- Conditions
- Female Infertility
- Keywords
- r-hLH, Cytokines, Follicular Fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro di Procreazione Assistita DemetraUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 28 Dec 2015 (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 objective of our observational prospective study will be to compare, for women treated for infertility and included in a ICSI program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other group on the basis of both embryo morphology and follicular fluid cytokines content.
100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who have had a low ovarian response, Fort < 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH , according to the standard established by our clinical practice.
Patients will be part of one of the following groups:
Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Single embryo transfer on day 5, according to standard embryo morphological criteria |
| Group 2 | – | –Single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Normogonadotropic Infertile Women that failed the first IVFcycle and require r-hLh add on therapy as per Demetra clinical standard procedures
Key inclusion criteria (3 listed)
- women age from < 38 years
- normal body mass index (BMI ) from 18 to 26
- parameters for ovarian reserve in the normal range (day 3 FSH levels < 10 mUI/ml ; day 3 E2 levels < 80 pg/ml; anti-mullerian hormone (AMH) levels > 1.5 ng/ml ; AFC (antral follicular count) > 6 )
Key exclusion criteria (4 listed)
- polycystic ovary syndrome (PCOS)
- ovarian surgery
- pelvic endometriosis
- POR according to ESHRE criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implantation rate
Time frame: 2 years
1 secondary outcome
Delivery Rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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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.
Elisabetta Chelo, MD principal investigator
Clinica Center DEMETRA
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 Female Infertility, run by Centro di Procreazione Assistita Demetra 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 3 inclusion and 4 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 3 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabetta Chelo, MD (0039 335457607, elisabetta.chelo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: 2 years). 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 3 Feb 2016.