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

NCT ID: NCT04458454

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-02-20

Brief Summary

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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

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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.

Conditions

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Infertility Reproductive Techniques, Assisted Oocyte Maturation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Relaxin ELISA Kit

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Olesya Nikolaevna Bespalova

Olesya Nikolaevna Bespalova, MD, PhD, DSci (Medicine), Deputy Director for Research. The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olesya N Bespalova, MD, DSci

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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DOOttResearch

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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DOOttResearch

Identifier Type: -

Identifier Source: org_study_id

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