Clinical trial NCT04458454: "Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles"
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" "
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Reproductive Techniques, Assisted
Oocyte Maturation
Keywords: Infertility
Relaxin
Oocytes
Embryo quality
IVF
Lead sponsor: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 11
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between the relaxin values in follicular fluid and the number of oocytes obtained
timeFrame: 10-14 days from the start of stimulation in the IVF protocol ( the day of transvaginal follicular puncture)
Secondary outcomes:
measure: Correlation between the relaxin levels in follicular fluid and oocyte fertilization efficiency
timeFrame: 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.
measure: Correlation between the relaxin levels in follicular fluid and age
timeFrame: 10-14 days from the start of stimulation in the IVF protocol
measure: Correlation between the relaxin levels in follicular fluid and BMI
timeFrame: 10-14 days from the start of stimulation in the IVF protocol
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: DOOttResearch
Study officials:
affiliation: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
name: Olesya N Bespalova, MD, DSci
role: PRINCIPAL_INVESTIGATOR
References: