Hormone Disturbance Clinical Trial
Official title:
Correlation of Progesterone Levels on the Day of Oocyte Retrieval With Basal Hormonal Status and the Outcome of in Vitro Fertilization in Women
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
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.
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