Clinical trial NCT04707430: The Effect of Progesterone Levels on Pregnancy
Official title: The Effect of Progesterone Levels on the 3rd and 5th Days After Insemination on Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relationship of Progesterone Levels and Pregnancy
Keywords: intrauterine insemination
progesterone
pregnancy
gonadotropins
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 156
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Hacettepe Hospital and scheduled for insemination

Brief summary: The aim of this study is to investigate the effect of progesterone levels on pregnancy occurrence on the 3rd and 5th days after insemination.

Detailed description: Ovarian stimulation with gonadotropins is a frequently used method in patients with unexplained infertility undergoing intrauterine insemination.

Pregnancy and live birth rates after ovarian stimulation; The number of follicles in ovulatory size and responsive to ovarian stimulation is affected by many factors such as the age of the woman and the duration of infertility. Progesterone production in the luteal phase is necessary to achieve successful treatment results by increasing the receptivity of the endometrium in the secretory phase.

In assisted reproductive techniques, exogenous progesterone support in the luteal phase is a routinely used method due to higher pregnancy rates, but there is no consensus with the use of progesterone in IUI applications. In a recent meta-analysis, a positive relationship was found between gonadotropins and progesterone support when ovulation induction and intrauterine insemination were performed, while this relationship was not found with clomiphene citrate, and although letrozole and gonadotropin were used together, no significant statistics were found.

The relationship between luteal phase hormone dynamics and pregnancy outcomes in IUI is not fully understood. Although luteal phase failure is mentioned, there is no accepted definition of luteal phase failure worldwide. In one study, progesterone concentrations in the midluteal phase and pregnancy outcomes were investigated in 188 IUI cycles, predicting that low levels could predict treatment failure. In another study, a positive relationship was found between luteal phase progesterone levels and clinical pregnancy outcomes.However, the relationship between blood progesterone levels and pregnancy rates in a small number of IUI cycles has been investigated in the literature. Considering all these studies, there is no Level 1 evidence regarding the benefit of providing progesterone support in groups where the progesterone level is below a certain threshold value. In this study, we aimed to investigate the relationship between gestational outcomes by looking at progesterone values on the 3rd and 5th days after IUI in patients who were decided to be treated with IUI. By looking at these progesterone levels, we aimed to determine a threshold value for the ideal level of progesterone in the luteal phase and to be a guide in terms of possible results and methods of shaping the treatment.

Eligibility criteria: Inclusion Criteria:

* Patients who have been decided for intrauterine insemination
* Patients under the age of 40
* Patients with a BMI of less than 40 kg / m2
* Cycles triggered by rhCG
* Those who have a signed and dated informed consent document that they have been informed about the study and that their consent has been obtained

Exclusion Criteria:

* Patients over the age of 40
* Patients with BMI over 40 kg / m2

Primary outcomes:
measure: The progesterone level
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Gurkan Bozdag, Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Galip Serdar Gunalp, Prof.
role: STUDY_CHAIR
References: