Serial Progesterone Level Measurements During the Menstrual Cycle in Subfertile Women

NCT05211583 | Unknown

• 1 other identifier: Progesterone
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subfertility, Female; Ovulation Disorder

Keywords

ovulation; progesterone; ovulatory dysfunction; subfertility

Outcome Measures

Primary Outcomes (2)

• Change of serum progesterone levels referenced to 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

  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.

Study Arms (1)

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

Interventions

Serum progesterone levels DIAGNOSTIC_TEST

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.

subfertile women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Turgut Aydın: lead

Study Sites (1)

Acibadem University

Istanbul, 34357, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Turgut Aydın

  Acibadem University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Turgut Aydın

CONTACT

+905323722713; turgut.aydin@acibadem.com

nadiye köroğlu

CONTACT

+905058065348; nadiye_dugan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: December 10, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)