Infertility"Relaxifert"NCT04458454
"Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles"
An observational study of Infertility and Reproductive Techniques, Assisted, run by D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology at 1 site in Russia.
Trial summary
The study evaluated the effect of serum relaxin and follicular fluid levels on the number and quality of oocytes, fertilization, the number and quality of the embryos in IVF protocols. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Infertility, Reproductive Techniques, Assisted, Oocyte Maturation
- What is being tested?
- Relaxin ELISA Kit
- How many people
- 11 participants
- Where
- 1 siteRussia
- Study dates
- 2 Dec 2019to 20 Feb 2020
- 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 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: The study included patients undergoing treatment in the Department of Assisted Reproductive Technologies of The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott, Saint Petersburg, Russia
Who may be able to join
- Clinical diagnosis of Primary or Secondary infertility
- Must be signed the voluntary informed consent to participate in the study.
Who cannot join
- The presence of IVF contra-indications.
- Clinical diagnosis of large uterine fibroids.
- BMI> 35 kg / m2
- Morphological diagnosis of endometrial hyperplastic processes
- Clinical diagnosis of infectious.
- Clinical diagnosis of systemic autoimmune diseases.
- Insulin dependent diabetes
- Oncological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles as a Part of the Project "Relaxifert" "
The study evaluated the effect of serum relaxin and follicular fluid levels on the number and quality of oocytes, fertilization, the number and quality of the embryos in IVF protocols.
Read the detailed description
Relaxin is one of the promising indicators of oocyte quality and prognosis of the effectiveness of invitro fertilization protocols. The hormone plays an important role in the processes of folliculogenesis, growth and maturation of oocytes, development of embryos, implantation processes, pregnancy and childbirth. A pilot study was conducted on a group of patients undergoing infertility treatment using assisted reproductive technologies in the superovulation stimulation protocol using gonadotropin releasing hormone antagonists. Blood and follicular fluid samples were obtained on the day of transvaginal follicular puncture. The results allow us to consider the hormone relaxin as a promising predictor of the result of ovarian stimulation, the effectiveness of fertilization in IVF cycles.
- Being tested
- Relaxin ELISA Kit
- Keywords
- Infertility, Relaxin, Oocytes, Embryo quality, IVF
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxin ELISA KitDiagnostic test
Ovarian stimulation was carried out from day 3 of the menstrual cycle using a fixed protocol, with recombinant (Gonal-F, Pergoveris) or human menopausal gonadotropins (Meriofert), GnRH antagonist (ganirelix 0.25 mg). A recombinant human chorionic gonadotropin Ovitrel 250 μg or a GnRH agonist, Diferelin 0.2 mg, was used as an ovulation trigger.
| Study group | Role | What they receive |
|---|---|---|
| Examination of relaxin levels | This is a pilot study of 1 group of patients. The analysis of relaxin levels in serum and follicular fluid obtained on the day of puncture of the follicles in patients undergoing treatment in the IVF protocol is carried out. Receives: Diagnostic Test: Relaxin ELISA Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the relaxin values in follicular fluid and the number of oocytes obtained
The level of relaxin in follicular fluid was estimated using an ELISA Kit for Relaxin 2. The range of detectable concentrations was 3.1-500 pg / ml. Higher relaxin concentrations in follicular fluid are associated with a higher number of oocytes obtained.
Measured: 10-14 days from the start of stimulation in the IVF protocol ( the day of transvaginal follicular puncture)
Secondary outcomes (3)
Correlation between the relaxin levels in follicular fluid and oocyte fertilization efficiency
The level of relaxin in follicular fluid was estimated using an ELISA Kit for Relaxin 2. The range of detected concentrations was 3.1-500 pg / ml. In course of standard IVF technique the fertilization efficacy was evaluated as a ratio of double pro-nucleus zygote on the 1st day of development to obtained oocyte-cumulus complexes number. In course of ICSI the efficacy was estimated as ratio of double pro-nucleus zygote on the 1st day of development to oocyte number on MII stage on puncture day. Higher concentrations of follicular fluid relaxin are associated with a decrease efficacy of oocyte fertilization
Measured: 10-14 days from the start of stimulation in the IVF protocol for relaxin. The first day after transvaginal follicular puncture for evaluation oocyte fertilization efficiency.
Correlation between the relaxin levels in follicular fluid and age
The method of relaxin determining in follicular fluid and the range of determined concentrations are described previously. With increasing age, a decrease in the concentration of relaxin in the follicular fluid was noted.
Measured: 10-14 days from the start of stimulation in the IVF protocol
Correlation between the relaxin levels in follicular fluid and BMI
The method of relaxin determining in follicular fluid and the range of determined concentrations are described previously. With increasing of BMI, a decrease in the concentration of relaxin in the follicular fluid was noted.
Measured: 10-14 days from the start of stimulation in the IVF protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start2 Dec 2019
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olesya Nikolaevna Bespalova, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
- Investigators
- Olesya N Bespalova, MD, DSci, Principal investigator, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458454
- Sponsor's protocol ID
- DOOttResearch
- Acronym
- "Relaxifert"
- Status last verified
- Jul 2020
- First submitted
- 9 May 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For this study, do not see the need to publish these data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles as a Part of the Project "Relaxifert" "
- ClinicalTrials.gov ID
- NCT04458454
- Acronym / sponsor ID
- "Relaxifert" / DOOttResearch
- Keywords
- Infertility, Relaxin, Oocytes, Embryo quality, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- D.O. Ott Research Institute of Obstetrics, Gynecology, and ReproductologyUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 7 Jul 2020 (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.
The study evaluated the effect of serum relaxin and follicular fluid levels on the number and quality of oocytes, fertilization, the number and quality of the embryos in IVF protocols.
Detailed description
Relaxin is one of the promising indicators of oocyte quality and prognosis of the effectiveness of invitro fertilization protocols. The hormone plays an important role in the processes of folliculogenesis, growth and maturation of oocytes, development of embryos, implantation processes, pregnancy and childbirth. A pilot study was conducted on a group of patients undergoing infertility treatment using assisted reproductive technologies in the superovulation stimulation protocol using gonadotropin releasing hormone antagonists. Blood and follicular fluid samples were obtained on the day of transvaginal follicular puncture. The results allow us to consider the hormone relaxin as a promising predictor of the result of ovarian stimulation, the effectiveness of fertilization in IVF cycles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Examination of relaxin levels | – | Diagnostic Test: Relaxin ELISA KitThis is a pilot study of 1 group of patients. The analysis of relaxin levels in serum and follicular fluid obtained on the day of puncture of the follicles in patients undergoing treatment in the IVF protocol is carried out. |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study included patients undergoing treatment in the Department of Assisted Reproductive Technologies of The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott, Saint Petersburg, Russia
Key inclusion criteria (2 listed)
- Clinical diagnosis of Primary or Secondary infertility
- Must be signed the voluntary informed consent to participate in the study.
Key exclusion criteria (8 listed)
- The presence of IVF contra-indications.
- Clinical diagnosis of large uterine fibroids.
- BMI> 35 kg / m2
- Morphological diagnosis of endometrial hyperplastic processes
- Clinical diagnosis of infectious.
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 |
|---|---|---|
| Relaxin ELISA KitOvarian stimulation was carried out from day 3 of the menstrual cycle using a fixed protocol, with recombinant (Gonal-F, Pergoveris) or human menopausal gonadotropins (Meriofert), GnRH antagonist (ganirelix 0.25 mg). A recombinant human chorionic gonadotropin Ovitrel 250 μg or a GnRH agonist, Diferelin 0.2 mg, was used as an ovulation trigger. | Diagnostic test | Examination of relaxin levels |
Primary outcome
Correlation between the relaxin values in follicular fluid and the number of oocytes obtained
Time frame: 10-14 days from the start of stimulation in the IVF protocol ( the day of transvaginal follicular puncture)
The level of relaxin in follicular fluid was estimated using an ELISA Kit for Relaxin 2. The range of detectable concentrations was 3.1-500 pg / ml. Higher relaxin concentrations in follicular fluid are associated with a higher number of oocytes obtained.
3 secondary outcomes
Correlation between the relaxin levels in follicular fluid and oocyte fertilization efficiency
Time frame: 10-14 days from the start of stimulation in the IVF protocol for relaxin. The first day after transvaginal follicular puncture for evaluation oocyte fertilization efficiency.
Correlation between the relaxin levels in follicular fluid and age
Time frame: 10-14 days from the start of stimulation in the IVF protocol
Correlation between the relaxin levels in follicular fluid and BMI
Time frame: 10-14 days from the start of stimulation in the IVF protocol
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 7 Jul 2020.
- Individual participant dataSharing planned: No. For this study, do not see the need to publish these data.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Olesya N Bespalova, MD, DSci principal investigator
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
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 Infertility and Reproductive Techniques, Assisted, run by D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology at 1 site in Russia.
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 2 inclusion and 8 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 7 Jul 2020. 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 Russia. 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?
Correlation between the relaxin values in follicular fluid and the number of oocytes obtained (time frame: 10-14 days from the start of stimulation in the IVF protocol ( the day of transvaginal follicular puncture)). 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 7 Jul 2020.