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

"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.

Study Overview

• Status: Completed
• Conditions: Infertility; Reproductive Techniques, Assisted; Oocyte Maturation
• Intervention / Treatment: Diagnostic test: Relaxin ELISA Kit

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 Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • DOOttResearch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 43 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Relaxin 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10-14 days from the start of stimulation in the IVF protocol ( the day of transvaginal follicular puncture)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	10-14 days from the start of stimulation in the IVF protocol

Collaborators and Investigators

• Sponsor: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
• Investigators: Principal Investigator: Olesya N Bespalova, MD, DSci, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2019
• Primary Completion (ACTUAL): February 20, 2020
• Study Completion (ACTUAL): February 20, 2020

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: IVF; Infertility; Relaxin; Oocytes; Embryo quality
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Muscle Relaxants, Central; Methocarbamol
• Other Study ID Numbers: DOOttResearch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For this study, do not see the need to publish these data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No