Variation of Progesterone in IVF Cycles

February 25, 2020 updated by: ART Fertility Clinics LLC
to examine if a natural daytime variation in progesterone levels may explain parts of the inconsistent findings from studies reporting divergent results concerning this matter and will be carried out by several blood samples from the same patient during the day of ovulation triggering.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The impact of the progesterone level at the end of the follicular phase in stimulated IVF/ICSI cycles and its effect on the pregnancy rate and oocyte quality is controversial, which arises from conflicting results in retrospective studies and meta-analyses. This study is assumed to examine if a natural daytime variation in progesterone levels may explain parts of the inconsistent findings from studies reporting divergent results concerning this matter and will be carried out by several blood samples from the same patient during the day of ovulation triggering. If variation is present, the impact of variation on the developing oocyte and embryo quality will be estimated by embryo quality indicators.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patient who will undergo IVF treatment

Description

Inclusion Criteria:

  • patients 18-45 years
  • BMI 18-35 kg/m2
  • Menstrual cycle length 24-35 days
  • Stimulation with rFSH or hMG

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The variation of serum progesterone around the ovulation triggering in IVF-cycles
Time Frame: 6-8 months
the circadian secretion-pattern of progesterone during early follicular phase of normal cycling females
6-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Upma Shanker, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2018

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1710-MUS-106-LB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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