Serial Progesterone Level Measurements During the Menstrual Cycle in Subfertile Women

• Conditions: Subfertility, Female; Ovulation Disorder
• Interventions: Diagnostic Test: Serum progesterone levels

• Registration Number: NCT05211583
• Lead Sponsor: Turgut Aydın

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-10
• Status Verified: 2022-01
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Primary Completion: 2022-03
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
subfertile women	Serum progesterone levels	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.

Primary Outcome Measures

Name	Time	Method
Change of reproductive hormone levels referenced to ovulation	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.
Change of serum progesterone levels 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	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.

Trial Locations

Locations (1)

Acibadem University; 🇹🇷 İstanbul, Turkey