Oocyte Retrieval Progesterone Levels and IVF

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447677
• Other study ID #: 25138
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 31, 2015

Study information

• Verified date: June 2020
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18 to 40 years of age

• BMI of 18 to 30 kg/m2

• regular menstrual cycles from 25 to 32 days

• established diagnosis of infertility.

Exclusion Criteria:

• Less then 18 or more then 40 years old

• BMI less then 18 or more then 30 kg/m2

• irregular menstrual cycles

Related Conditions & MeSH terms

• Endocrine System Diseases
• Hormone Disturbance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome of Ivf procedure	Outcome of ivf procedure can be positive and devided in pregnancies, miscariages or biochemical pregnancies or can be negative outcome -failire of procedure	12 months