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Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles

Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles as a Part of the Project Relaxifert

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04458454
Acronym
Relaxifert
Enrollment
11
Registered
2020-07-07
Start date
2019-12-02
Completion date
2020-02-20
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Oocyte Maturation, Reproductive Techniques, Assisted

Keywords

Infertility, Relaxin, Oocytes, Embryo quality, IVF

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTRelaxin ELISA Kit

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.

Sponsors

D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 43 Years
Healthy volunteers
No

Inclusion criteria

1. Clinical diagnosis of Primary or Secondary infertility 2. Must be signed the voluntary informed consent to participate in the study.

Exclusion criteria

1. The presence of IVF contra-indications. 2. Clinical diagnosis of large uterine fibroids. 3. BMI\> 35 kg / m2 4. Morphological diagnosis of endometrial hyperplastic processes 5. Clinical diagnosis of infectious. 6. Clinical diagnosis of systemic autoimmune diseases. 7. Insulin dependent diabetes 8. Oncological diseases

Design outcomes

Primary

MeasureTime frameDescription
Correlation between the relaxin values in follicular fluid and the number of oocytes obtained10-14 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.

Secondary

MeasureTime frameDescription
Correlation between the relaxin levels in follicular fluid and oocyte fertilization efficiency10-14 days from the start of stimulation in the IVF protocol for relaxin. The first day after transvaginal follicular puncture for evaluation oocyte fertilization efficiency.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
Correlation between the relaxin levels in follicular fluid and age10-14 days from the start of stimulation in the IVF protocolThe 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.
Correlation between the relaxin levels in follicular fluid and BMI10-14 days from the start of stimulation in the IVF protocolThe 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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026