InfertilityNCT02877992
Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells
A study testing Ovarian puncture in people with Infertility, run by Vida Recoletas Sevilla at 2 sites in Spain.
Trial summary
The purpose of this project is to study the presence of expression differences - at RNA and protein level - of different members of the tachykinin family and kisspeptin and their receptors, between fertile women and infertile patients with different etiologies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Ovarian puncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2014to Jul 2019
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 34 years
- Normal caryotype
- Normal psychological test
- Age between 18 and 45 years
- One of the following etiologies:
- Patient with PCOS according to Rotterdam Criteria or
Show all 9Show fewer
- Patients with endometriosis stage I-IV or
- Patients with low ovarian response according to Bologna criteria or
- Patients with advances maternal age (between 38 and 45 years)
Who cannot join
- Presence of hereditary diseases
- Beta-thalassemia
- Cystic fibrosis
- Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV)
- Infertility patients
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Instituto de Investigaciones Químicas
Seville, 41011
IVI Sevilla
Seville, 41011
About this study
Official title: Development of a New Diagnostic Tool to Assess Oocyte Quality Based on Tachykinin and Kisspeptin Expression Analysis in Human Granulosa and Cumulus Cells
The purpose of this project is to study the presence of expression differences - at RNA and protein level - of different members of the tachykinin family and kisspeptin and their receptors, between fertile women and infertile patients with different etiologies.
- Conditions
- Infertility
- Being tested
- Ovarian puncture
- Keywords
- Infertility, Tachykinin, Kisspeptin
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian punctureProcedure or surgery
Donors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study.
| Study group | Role | What they receive |
|---|---|---|
| Donors | Active comparator | Oocyte donors without infertility problems Receives: Procedure: Ovarian puncture |
| PCOS | Experimental | Patients with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria Receives: Procedure: Ovarian puncture |
| Endometriosis | Experimental | Patients with endometriosis (I-IV) Receives: Procedure: Ovarian puncture |
| Age | Experimental | Patients with advanced maternal age (38 years or more) Receives: Procedure: Ovarian puncture |
| Low ovarian response | Experimental | Patients with low ovarian response according to Bologna criteria Receives: Procedure: Ovarian puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression level of Substance P (SP)
Expression analysis at mRNA (mRNA = messenger ribonucleic acid) and protein level using techniques of real time quantitative PCR (PCR = polymerase chain reaction), immunocytochemistry and western blot
Measured: 4 years
Expression level of neurokinin A (NKA)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Measured: 4 years
Expression level of neurokinin B (NKB)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Measured: 4 years
Expression level of hemokinin 1 (HK-1)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Measured: 4 years
Expression level of neurokinin 1 receptor (NK1R)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Measured: 4 years
Expression of neurokinin 2 receptor (NK2R)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Measured: 4 years
Expression level of neurokinin 3 receptor (NK3R)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Measured: 4 years
Expression level of kisspeptin 1 (KISS1)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Measured: 4 years
Expression level of kisspeptin 1 receptor (KISS1R)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Measured: 4 years
Secondary outcomes (12)
Patient or donor age
Years
Measured: 4 years
Patient or donor body mass index
kg/m2
Measured: 4 years
Years of infertility
Number of years that the patient has been trying to have a child without success
Measured: 4 years
Estradiol level (day of ovulation induction)
Estradiol level in blood (pg/mL), measured the day in which ovulation is induced
Measured: 4 years
Progesterone level (day of ovulation induction)
Progesterone level in blood (ng/mL), measured the day in which ovulation is induced
Measured: 4 years
Number of oocytes retrieved in the ovarian puncture
Measured: 4 years
Number of mature oocytes (metaphase II) obtained in the ovarian puncture
Measured: 4 years
Fertilization rate
Proportion of oocytes correctly fertilized (2 pronuclei and 2 polar bodies) after the ICSI (ICSI = intracytoplasmic sperm injection) procedure
Measured: 4 years
Embryo quality
Embryo quality at day 3 of embryo development (of each embryo of the cohort). Quality assessed according to ASEBIR (ASEBIR = "Asociación Española para el estudio de la Biología de la Reproducción" = Spanish society for reproductive biology) criteria. Embryo quality grade A to D.
Measured: 4 years
Daily and total dose of FSH (FSH = follicle stimulating hormone)
Daily dose of FSH for controlled ovarian stimulation. International Units (IU)
Measured: 4 years
Daily and total dose of HMG (HMG = human menopausal gonadotropin)
Daily dose of HMG for controlled ovarian stimulation. International Units (IU)
Measured: 4 years
Type of ovulation induction
Ovulation induction using 6500 IU of hCG (hCG = human chorionic gonadotropin) or 0.2 mg of triptorelin (Decapeptyl)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Fernandez-Sanchez, Vida Recoletas Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877992
- Sponsor's protocol ID
- IVISEVILLA
- Status last verified
- Feb 2020
- First submitted
- 12 Aug 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
Publications
Garcia-Ortega J, Pinto FM, Fernandez-Sanchez M, Prados N, Cejudo-Roman A, Almeida TA, Hernandez M, Romero M, Tena-Sempere M, Candenas L. Expression of neurokinin B/NK3 receptor and kisspeptin/KISS1 receptor in human granulosa cells. Hum Reprod. 2014 Dec;29(12):2736-46. doi: 10.1093/humrep/deu247. Epub 2014 Oct 14.
PubMed 25316443Garcia-Ortega J, Pinto FM, Prados N, Bello AR, Almeida TA, Fernandez-Sanchez M, Candenas L. Expression of Tachykinins and Tachykinin Receptors and Interaction with Kisspeptin in Human Granulosa and Cumulus Cells. Biol Reprod. 2016 Jun;94(6):124. doi: 10.1095/biolreprod.116.139881. Epub 2016 May 4.
PubMed 27146034
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Diagnostic Tool to Assess Oocyte Quality Based on Tachykinin and Kisspeptin Expression Analysis in Human Granulosa and Cumulus Cells
- ClinicalTrials.gov ID
- NCT02877992
- Acronym / sponsor ID
- IVISEVILLA
- Conditions
- Infertility
- Keywords
- Infertility, Tachykinin, Kisspeptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 25 Aug 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 purpose of this project is to study the presence of expression differences - at RNA and protein level - of different members of the tachykinin family and kisspeptin and their receptors, between fertile women and infertile patients with different etiologies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Donors | Active comparator | Procedure: Ovarian punctureOocyte donors without infertility problems |
| PCOS | Experimental | Procedure: Ovarian puncturePatients with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria |
| Endometriosis | Experimental | Procedure: Ovarian puncturePatients with endometriosis (I-IV) |
| Age | Experimental | Procedure: Ovarian puncturePatients with advanced maternal age (38 years or more) |
| Low ovarian response | Experimental | Procedure: Ovarian puncturePatients with low ovarian response according to Bologna criteria |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age between 18 and 45 years
- One of the following etiologies:
- Patient with PCOS according to Rotterdam Criteria or
- Patients with endometriosis stage I-IV or
- Patients with low ovarian response according to Bologna criteria or
Key exclusion criteria (5 listed)
- Infertility patients
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 |
|---|---|---|
| Ovarian punctureDonors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study. | Procedure or surgery | Age, Donors, Endometriosis, Low ovarian response, PCOS |
Primary outcome
Expression level of Substance P (SP)
Time frame: 4 years
Expression analysis at mRNA (mRNA = messenger ribonucleic acid) and protein level using techniques of real time quantitative PCR (PCR = polymerase chain reaction), immunocytochemistry and western blot
Expression level of neurokinin A (NKA)
Time frame: 4 years
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of neurokinin B (NKB)
Time frame: 4 years
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of hemokinin 1 (HK-1)
Time frame: 4 years
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of neurokinin 1 receptor (NK1R)
Time frame: 4 years
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression of neurokinin 2 receptor (NK2R)
Time frame: 4 years
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of neurokinin 3 receptor (NK3R)
Time frame: 4 years
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of kisspeptin 1 (KISS1)
Time frame: 4 years
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of kisspeptin 1 receptor (KISS1R)
Time frame: 4 years
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
12 secondary outcomes
Patient or donor age
Time frame: 4 years
Patient or donor body mass index
Time frame: 4 years
Years of infertility
Time frame: 4 years
Estradiol level (day of ovulation induction)
Time frame: 4 years
Progesterone level (day of ovulation induction)
Time frame: 4 years
Number of oocytes retrieved in the ovarian puncture
Time frame: 4 years
Number of mature oocytes (metaphase II) obtained in the ovarian puncture
Time frame: 4 years
Fertilization rate
Time frame: 4 years
Embryo quality
Time frame: 4 years
Daily and total dose of FSH (FSH = follicle stimulating hormone)
Time frame: 4 years
Daily and total dose of HMG (HMG = human menopausal gonadotropin)
Time frame: 4 years
Type of ovulation induction
Time frame: 4 years
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 13 Feb 2020.
- Background: PubMed 25316443Garcia-Ortega J, Pinto FM, Fernandez-Sanchez M, Prados N, Cejudo-Roman A, Almeida TA, Hernandez M, Romero M, Tena-Sempere M, Candenas L. Expression of neurokinin B/NK3 receptor and kisspeptin/KISS1 receptor in human granulosa cells. Hum Reprod. 2014 Dec;29(12):2736-46. doi: 10.1093/humrep/deu247. Epub 2014 Oct 14.
- Results publication: PubMed 27146034Garcia-Ortega J, Pinto FM, Prados N, Bello AR, Almeida TA, Fernandez-Sanchez M, Candenas L. Expression of Tachykinins and Tachykinin Receptors and Interaction with Kisspeptin in Human Granulosa and Cumulus Cells. Biol Reprod. 2016 Jun;94(6):124. doi: 10.1095/biolreprod.116.139881. Epub 2016 May 4.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian puncture in people with Infertility, run by Vida Recoletas Sevilla at 2 sites 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 9 inclusion and 5 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Expression level of Substance P (SP) (time frame: 4 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877992, which also lists 2 linked publications.
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 13 Feb 2020.