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NCT Number: NCT04458454

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

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.

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Key information

Conditions

Infertility Behavior Genital Diseases Helping Behavior Oocyte Maturation Reproductive Techniques, Assisted Social Behavior Urogenital Diseases

Age range

20 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

DOOttResearch

Saint Petersburg, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Relaxin ELISA Kit

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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

  2. Correlation between the relaxin levels in follicular fluid and age

    Time frame: 10-14 days from the start of stimulation in the IVF protocol

    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.

  3. Correlation between the relaxin levels in follicular fluid and BMI

    Time frame: 10-14 days from the start of stimulation in the IVF protocol

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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" "

Acronym: "Relaxifert"

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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