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

Infertility Clinical Trial

— "Relaxifert"  

Official 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" "

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458454
• Other study ID #: DOOttResearch
• Status: Completed
• Start date: December 2, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: July 2020
• Source: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Oocyte Maturation
• Reproductive Techniques, Assisted

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	DOOttResearch	Saint Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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