Current partner codePEPTIDESDE
NCT04458454·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

11

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jul 7, 2020

  2. Study start

    Dec 2, 2019

  3. Primary completion

    Feb 20, 2020

  4. Study completion

    Feb 20, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Jul 7, 2020

Outcomes

What the study measures.

Primary outcomes

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

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

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.

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.

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
43 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

Russia. Showing up to 24 locations stored in the fast local snapshot.

DOOttResearch

Saint Petersburg, Russia

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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