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

NCT04458454 | Completed

• 1 other identifier: DOOttResearch
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Reproductive Techniques, Assisted; Oocyte Maturation

Keywords

Infertility; Relaxin; Oocytes; Embryo quality; IVF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between the relaxin levels in follicular fluid and oocyte fertilization efficiency

  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

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

• Correlation between the relaxin levels in follicular fluid and BMI

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

Study Arms (1)

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

Interventions

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.

Examination of relaxin levels

Eligibility Criteria

• Age: 20 Years - 43 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

DOOttResearch

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Infertility; Helping Behavior

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Study Officials

• Olesya N Bespalova, MD, DSci

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Olesya Nikolaevna Bespalova, MD, PhD, DSci (Medicine), Deputy Director for Research. The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: July 7, 2020
• Study Start: December 2, 2019
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)