Serial Progesterone Level Measurements During the Menstrual Cycle in Subfertile Women

January 14, 2022 updated by: Turgut Aydın

Evaluation of Serum Hormone Levels Referenced to Ovulation in Subfertile Women With Regular Menses

Ovulatory dysfunction is identified in 15% of all infertile couples and it accounts for 40% of female infertility. Ovulatory dysfunction may be more subtle in women with regular menses. Detecting the day of ovulation is necessary for optimizing natural conception, diagnosis of cycle disturbances and also timing for embryo transfer in natural cycle frozen-thawed embryo transfers. In order to diagnose ovulatory dysfunction, ovulation physiology and change of reproductive hormones during the menstrual cycle should be understood. In the present study we aimed to evaluate serial serum hormonal cut-off levels referenced to ovulation in subfertile women with regular menses.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population will be selected from women who attended to Acıbadem University Atakent Hospital Infertility Clinic for evaluation of infertility.

Description

Inclusion Criteria:

  • women that have regular menses (menstrual cycle length 21-35 days)
  • women who will come visits regularly
  • women that are trying to conceive more than 1 year if women age is less than 35 years or more than 6 months if women age is >35 years

Exclusion Criteria:

  • women who do not menstruate regularly
  • women that use hormonal contraception
  • women who take drugs that will interfere with steroid hormone metabolism

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
subfertile women
Subfertile women with regular menses (menstrual cycle length range from 21 to 35 days) will be examined by transvaginal ultrasonography at menstruation, before the anticipated date of ovulation and after ovulation. Serum hormone levels will be measured at menstruation, before ovulation and after ovulation with a serial manner.
Diagnostic test: Serum progesterone levels
In order to show change of serum progesterone levels, serial venous blood sampling will be done and also transvaginal ultrasonography will be performed to show ovulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of serum progesterone levels referenced to ovulation
Time Frame: Progesterone levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation; 1 week after ultrasound and hormone-detected ovulation
Serum progesterone levels will be measured when dominant follicule is 17 mm in diameter and then serial measurements of hormones will be done and ovulation will be detected both hormonally and ultrasonographically. The range of serum progesterone will be reported referenced to ovulation.
Progesterone levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation; 1 week after ultrasound and hormone-detected ovulation
Change of reproductive hormone levels referenced to ovulation
Time Frame: Estradiol and LH levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation.
Serum estradiol and luteinising hormone (LH) levels will be measured when dominant folicule is 17 mm in diameter and then serial measurements of hormones will be done and ovulation will be detected both hormonally and ultrasonographically. The ranges for serum hormones will be reported.
Estradiol and LH levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation.

Collaborators and Investigators

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

Sponsor

Turgut Aydın

Investigators

  • Principal Investigator: Turgut Aydın, Acibadem University

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)

December 10, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Progesterone

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Subfertility, Female

Clinical Trials on Serum progesterone levels

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe