NCT04447677

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

June 11, 2020

Last Update Submit

June 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study evaluated 164 patients undergoing ART procedure - oocyte retrieval and embryo transfer in our Clinic. Patients in average had 34.66 ± 3.39 years, mean BMI was 22.23 ± 2.65, and their infertility mostly lasted for 4.86 ± 2.61 years (range 1 to 17 years). The mean P4 values on OR day were 1.26 ± 0.46 ng/ml in group P4 \<2ng/ml, while in the group of patients with P4 values ≥2ng/ml, the average P4 was 3.74 ± 1.62 ng/ml.

You may qualify if:

  • to 40 years of age
  • BMI of 18 to 30 kg/m2
  • regular menstrual cycles from 25 to 32 days
  • established diagnosis of infertility.

You may not qualify if:

  • Less then 18 or more then 40 years old
  • BMI less then 18 or more then 30 kg/m2
  • irregular menstrual cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent Professor

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 25, 2020

Study Start

January 1, 2015

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

June 25, 2020

Record last verified: 2020-06