Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03876145 |
| Other study ID # |
Royan-Female Infertility |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 12, 2016 |
| Est. completion date |
November 20, 2020 |
Study information
| Verified date |
February 2019 |
| Source |
Royan Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is a randomized controlled clinical trial to compare the pregnancy outcomes of
mild and minimal stimulation in infertile women with polycystic ovarian syndrome. The study
population consisted of all infertile women with polycystic ovary syndrome based on Rotterdam
criteria who have not succeed to achieve fertility despite multiple treatments such as drug
therapy, laparoscopic surgery, and the frequent failure of induction therapy using
gonadotropins and are now candidate for in vitro fertilization (IVF) or intra cytoplasmic
sperm injection (ICSI) in Reproductive Biomedicine Research Center, Royan institute, Tehran
Iran.
Description:
An overview of the history of assisted reproductive technologies such as IVF and ICSI that
are based on the process of ovulation stimulation, suggests that although this process was
initially welcomed with the aim of achieving a large number of oocytes and embryos,
consequences such as low quality of obtained oocytes and embryos, failure in achieving the
desired results in fertility of treated patients, and the incidence of adverse effects such
as ovarian hyper stimulation syndrome have made researchers re-examine the process of
ovulation stimulation. Hence, mild ovulation stimulation method has been introduced to the
field of assisted reproductive techniques (ART) in recent years. This method includes the
prescription of low doses of gonadotropins or shorter duration of its administration in the
ovulation stimulation cycle. Mild ovulation method has advantages such as reduction of the
physical, mental, and financial risks of treatment which can improve the quality assisted
reproductive services provided for infertile couples.
Several studies have confirmed the efficiency of this method of ovulation stimulation as a
way for improving the quality of the ovulation process and achieving desirable results in
fertility. However, the important and interesting point in studies conducted in this area,
particularly on IVF and ICSI cycles, is that the application of this method has been mostly
investigated in normal populations and, after the approval of its efficiency, it has been
recommended to be used in patients with poor or high ovarian response. It should be also
mentioned that efficiency of this method in patients with poor ovarian response has been
evaluated in a few studies, while in patients with high ovarian response such as those
suffering from polycystic ovary syndrome, only few studies have been conducted in patients
with a history of ovarian hyper stimulation syndrome. On the other hand, in many cases, the
efficiency of mild ovulation stimulation, in which lower doses or shorter durations of
gonadotropin administration are desired, has been investigated, and the application of
minimal ovulation stimulation method, in which the use of clomiphene citrate is also included
besides lower doses or shorter durations of gonadotropin administration, has been studied in
a few cases.
In addition to the dose and duration of gonadotropin administration, another important point
in achieving the desired results of treatment using the ovulation stimulation cycles is the
type of gonadotropin. The studies conducted on the comparison of recombinant-FSH (rec-FSH)
and Human Menopausal Gonadotropin (HMG) types of gonadotropin indicate the superiority of HMG
gonadotropins, as the results show that the administration of HMG gonadotropins will lead to
achieving fewer but high quality oocytes and embryos. By contrast, rec-FSH application puts
the patients at increased risk of ovarian hyper stimulation syndrome. However, the
interesting and important point in most of these studies is that this comparison has been
drawn in long-term treatment cycles, while few studies have been conducted on antagonist
treatment cycles which do not fully corroborate the results obtained from long-term cycles.
According to what mentioned above, the present research aims to study the efficiency of
minimal ovulation stimulation method in the treatment of infertile patients with poly cystic
ovarian syndrome (PCOS) and also the effect of gonadotropin type on treatment cycles with
antagonist gonadotropin-releasing hormone (GnRH). It is hoped that the findings of the
present research provide solutions for improving the quality of infertility treatment in PCOS
patients, who currently undergo IVF or ICSI as a last resort.
