Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04707430 |
| Other study ID # |
HU1101 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2020 |
| Est. completion date |
August 1, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Hacettepe University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
