Clinical Trials Directory

Trials / Completed

CompletedNCT04447677

Oocyte Retrieval Progesterone Levels and IVF

Correlation of Progesterone Levels on the Day of Oocyte Retrieval With Basal Hormonal Status and the Outcome of in Vitro Fertilization in Women

Status
Completed
Phase
Study type
Observational
Enrollment
164 (actual)
Sponsor
University of Belgrade · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

Summary

Objective: To assess whether basal hormonal level can predict the elevation of P4 on the day of oocyte retrieval, as well as to examine the impact of P4 elevation on the day of oocyte retrieval on the outcome of assisted reproduction. Design: Prospective cohort study Setting: Department of In Vitro Fertilization, Gynecology and Obstetrics Institute, Clinical Center of Serbia Patient(s): One hundred sixty four patients enrolled in the ART procedure Main Outcome Measure(s): Pregnancies, miscarriages, biochemical pregnancies and deliveries

Detailed description

A prospective clinical trial was conducted at the Clinic for Gynecology and Obstetrics Clinical Center of Serbia from January 1st to December 31st 2015. The study included 164 patients enrolled in the ART procedure at the Clinic. Basal hormonal status - serum levels of estradiol (E2 - pg/ml), progesterone (P4 - ng/ml), follicle-stimulating hormone (FSH - mIU/ml), luteinizing hormone (LH - mIU/ml) and anti-Mullerian hormone (AMH - ng/l) were measured on the 2ndor 3rd cycle day before stimulation commencement. During COS levels of estradiol were determined, while levels of progesterone were determined on the day of oocyte retrieval i.e. aspiration. Blood samples were taken by Vacutainer tubes (BD Vacutainer Systems) and centrifuged according to the manufacturer's instructions for the preparation of the serum samples. AMH value (Gen II ELISA ref. No. A79765; Beckman Coulter) in serum was measured by ELISA (enzyme-linked immunosorbent assay), 1 ng / ml). FSH, LH, estradiol, and progesterone were analyzed by chemiluminescent immunoassay (Access 2 immunoassay system, Beckman Coulter). The main outcome measures were the procedure success as well as the pregnancy outcome. Pregnancy was confirmed by a positive finding of serum β-hCG (\>25 MIU/ml) 14 days after embryo transfer. Clinical pregnancies were confirmed by transvaginal ultrasound findings of a gestational sac with a vital embryo at the 6th gestational week.

Conditions

Interventions

TypeNameDescription
OTHER

Timeline

Start date
2015-01-01
Primary completion
2015-12-31
Completion
2015-12-31
First posted
2020-06-25
Last updated
2020-06-25

Source: ClinicalTrials.gov record NCT04447677. Inclusion in this directory is not an endorsement.