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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05211583
Other study ID # Progesterone
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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