Serial Progesterone Level Measurements During the Menstrual Cycle in Subfertile Women

Ovulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211583
• Other study ID #: Progesterone
• Status: Recruiting
• Start date: December 10, 2021
• Est. completion date: April 2022

Study information

• Verified date: January 2022
• Source: Acibadem University
• Contact: Turgut Aydin
• Phone: +905323722713
• Email: turgut.aydin[@]acibadem.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Ovulation Disorder
• Subfertility, Female

Intervention

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.

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Turgut Aydin

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.