Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05300841 |
Other study ID # |
ICSI in PCOS patients |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
May 1, 2022 |
Est. completion date |
May 1, 2023 |
Study information
Verified date |
April 2022 |
Source |
Sohag University |
Contact |
Ahmed Salah |
Phone |
0201050199550 |
Email |
ahmedsalahali37[@]yahoo.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
To analyze the effect of pretreatment with dydrogesterone vs combined estradiol valerate and
dydrogesterone on embryologic parameters, chemical and clinical pregnancy rates of ICSI in
women with PCOS.
Description:
Polycystic ovary syndrome (PCOS) is a very common endocrine disorder affecting 5-7% of women
in reproductive age. It is the leading cause of anovulatory infertility in this age group. It
is characterized by ovulatory dysfunction, hyperandrogenism and polycystic ovary morphology
on ultrasonography.
Assisted reproductive techniques (ART) are indicated when infertile women with PCOS are
unable to become pregnant through standard ovulation induction methods. Many protocols have
been used for ovulation induction in ICSI , GNRH agonist and GNRH antagonist protocols are
the most commonly used nowadays. GNRH antagonist protocol use has been increased due to its
high safety profile and progressive physician experience in controlled ovarian stimulation .
Steroid pretreatment is steroid administration in the cycle preceding the ICSI cycle. Due to
oligo-menorrhea & unpredictability of menstruation in PCOS, steroid pretreatment is used to
schedule the start of an ICSI cycle in women with PCOS. Also, it is expected to synchronize
(homogenize) the follicular cohort, and thus increase both oocyte yield and gamete quality.
Moreover, steroid pretreatment may have an impact on cycle outcome.
For these reasons, more attention has been paid to the potential interest of steroid
pretreatments for scheduling GnRH antagonist cycles. Three main options have been used to
achieve cycle programming. First the combined oral contraceptive pill (COCS)seems to be
effective for scheduling menstruation but is not associated with increased oocyte yield .
Furthermore, a meta-analysis pointed out that COCS pretreatment may be associated with fewer
clinical pregnancies.Second, synthetic progestogens are good candidates because of their
potent suppressive effect on pituitary gonadotrophin secretion and was associated with higher
clinical pregnancy rate than COCS, placebo or no treatment. Finally, luteal administration of
natural estrogens was proved to improve the synchronization of early antral follicle growth
and to allow retrieval of two additional oocytes.
Either waiting for a spontaneous menses or using progestin is a better option than using COCs
to induce menses in women with PCOS prior to ovarian stimulation using GnRH antagonist
protocol for IVF. PCOS women using COCs had a lower live birth rate after fresh embryo
transfer when compared with women using progestin for inducing menses or those with
spontaneous menses. This difference, however, was not observed in the group who received an
FET.
Dydrogesterone (DYD) is one of the synthetic forms of progesterone whose molecular structure
and pharmacologic properties are closely related to endogenous progesterone .It is an orally
active progestin that is non-thermogenetic, non-sedative and does not inhibit gonadotropin
release and ovulation. It has weak antimineralocorticoid effects, negligible androgenic and
glucocorticoid activities, and no antiandrogenic properties . Levonorgestrel (LNG) and
Norgestrel (NG) are potent progestin exerting some androgenic activity, but no glucocorticoid
or antimineralocorticoid properties .
Estradiol valerate is an estradiol ester, or a prodrug of estradiol. As such, it is an
estrogen, or an agonist of the estrogen receptors. The affinity of estradiol valerate for the
estrogen receptor is approximately 50 times lower than that of estradiol . In addition,
estradiol valerate is rapidly cleaved into estradiol and is unable to reach target tissues in
concentrations of significance, if at all .As such, estradiol valerate is essentially
inactive in terms of estrogenic effect itself, acting solely as a prodrug to estradiol .
Aside from dose adjustment to account for the difference in molecular weight, oral estradiol
valerate is considered to be equivalent to oral estradiol. Because estradiol valerate is a
prodrug of estradiol, it is considered to be a natural and bioidentical form of estrogen.
The current study aims to analyze the effect of pretreatment with dydrogestrone vs combined
estradiol valerate and dydrogestrone on embryologic parameters, chemical and clinical
pregnancy rates of ICSI for PCOS patients. The current study, being prospective and
randomized, will differ from most of the previously conducted studies using steroid
pretreatment in ICSI for PCOS patients. It also differs in comparing the pretreatment with
dydrogesrone which is similar to natural progesterone with estradiol valerate which is
similar to natural estradiol, together with Dydrogestrone.