Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04549649 |
| Other study ID # |
Research ID (96000024) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
Royan Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Recently, in patients with a suboptimal ovarian response, a study of the role of adding a
single dose of GnRH agonist to a standard dose of hCG to initiate final oocyte maturation has
also been studied. Griffin et al. (2014) reported that in patients who had more than 25%
immature oocytes in their previous IVF cycle, the use of dual stimulation could increase the
number of mature oocytes. Since studies in this field are limited, the researchers decided to
design a clinical trial to investigate the effect of adding a GnRH agonist to a standard dose
of hCG to initiate final oocyte maturation in patients with a sub-optimal ovarian response.
Description:
Ovulation stimulation will be performed in all patients with the Standard GnRH antagonist
Protocol with E2 priming, with the antagonist protocol administered in all patients from the
20th cycle until the start of the next menstrual cycle with 4 mg of estradiol daily. Blood
sampling (FSH, LH, and estradiol levels) will be performed on the second day of the menstrual
cycle, just before gonadotropin stimulation. Ovarian stimulation will start from the second
or third day of menstruation with a maximum dose of 225 units of rFSH (Gonal -F: Serono
Laboratories Ltd, Geneva, Switzerland), and then if the follicle is observed, start with 13
injections of GnRH antagonist (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc)). From
the seventh day of the cycle, the dose of rFSH will be determined according to the rate of
ovarian response by vaginal ultrasonography two days in advance. If you see at least 2
follicles 18 mm in size or more, the antagonist will be injected. GnRH and gonadotropins
(Gonal-F) will stop and (oocyte triggering) will be the final stimulation of oocyte
maturation, at this time, the block randomization method will be designed to randomize
allocation of patients into groups with blocks of size 4. Recently, in patients with a
suboptimal ovarian response, a study of the role of adding a single dose of GnRH agonist to a
standard dose of hCG to initiate final oocyte maturation has also been studied. Griffin et
al. (2014) reported that in patients who had more than 25% immature oocytes in their previous
IVF cycle, the use of dual stimulation could increase the number of mature oocytes. Since
studies in this field are limited, the researchers decided to design a clinical trial to
investigate the effect of adding a GnRH agonist to a standard dose of hCG to initiate final
oocyte maturation in patients with a suboptimal ovarian response.
Controlled Ovulation stimulation (COS) will be performed in all patients with the Standard
GnRH antagonist Protocol with E2 priming, with the antagonist protocol administered in all
patients from the 20th cycle until the start of the next menstrual cycle with 4 mg of
estradiol daily. Blood sampling (FSH, LH, and estradiol levels) will be performed on the
second day of the menstrual cycle, just before gonadotropin stimulation. Ovarian stimulation
will start from the second or third day of menstruation with a maximum dose of 225 units of
rFSH (Gonal -F: Serono Laboratories Ltd, Geneva, Switzerland), and then if the follicle is
observed, start with 13 injections of GnRH antagonist (Cetrotide®, 0.25 mg cetrorelix
acetate, Serono, Inc)). From the seventh day of the cycle, the dose of rFSH will be
determined according to the rate of ovarian response by vaginal ultrasonography two days in
advance. If you see at least 2 follicles 18 mm in size or more, the antagonist will be
injected. GnRH and gonadotropins (Gonal-F) will stop and (oocyte triggering) will be the
final stimulation of oocyte maturation, at this time, the block randomization method will be
designed to randomize allocation of patients into groups with blocks of size 4. The required
number of blocks will be randomly selected according to sample size.
The final ovarian stimulation (oocyte triggering) will be performed in groups A and B as
follows:
Group A (Experimental): 0.2 mg Triptorelin (Decapeptyl; Ferring GmbH) associated with two
ampoules of Ovitrelle (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be administered
subcutaneously simultaneously.
Group B (Control): Two ampoules of Ovitrelle® (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc)
will be injected subcutaneously.
The COS cycles with less than two follicles will be cancelled s. Ovum pick up is performed
32-34 hours after oocyte triggering, and subsequently intracytoplasmic sperm injection (ICSI)
/in-vitro fertilization (IVF) will be done for all the patients.
The main outcome measures are the number of dominant follicles (≥13 mm) on the day of hCG
trigger and the number of mature (MII) oocytes collected after conventional versus
delayed-start ovarian stimulation protocol. Secondary outcome measures are including total
number of oocytes retrieved, oocyte maturity rate (number of MII oocytes/total number of
oocytes), oocyte yield (total number of oocytes retrieved/ antral follicle count [AFC]),
mature oocyte yield (number of mature oocytes retrieved/AFC), total dosage of gonadotropin
(recombinant FSH and/or highly purified hMG) needed, number of days needed for ovarian
stimulation, quality of obtained embryos, fertilization rate (the proportion of total number
of two-pronuclear [2PN] stage zygotes /per total injected MII oocytes), implantation rate
(total number of observed gestational sac/ number of transferred embryos) and clinical
pregnancy rate (presence of fetal heart beat by transvaginal ultrasound per embryo transfer).
