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

Completed

• Conditions: Reproductive Techniques, Assisted; Infertility; Oocyte Maturation
• Interventions: Diagnostic Test: Relaxin ELISA Kit

• Registration Number: NCT04458454
• Lead Sponsor: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

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.

Study Timeline

• Study Start: 2019-12-02
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Study First Submitted: 2020-05-09
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-02
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Examination of relaxin levels	Relaxin ELISA Kit	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.

Primary Outcome Measures

Name	Time	Method
Correlation between the relaxin values in follicular fluid and the number of oocytes obtained	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 Outcome Measures

Name	Time	Method
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.	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 age	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.
Correlation between the relaxin levels in follicular fluid and BMI	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.

Trial Locations

Locations (1)

DOOttResearch; 🇷🇺 Saint Petersburg, Russian Federation