Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03134690 |
| Other study ID # |
Royan-Emb-028 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2016 |
| Est. completion date |
June 2018 |
Study information
| Verified date |
February 2023 |
| Source |
Royan Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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).
Description:
One of the principal steps to obtain the favorable success is still related to the number of
retrieved oocytes after hormonal stimulation by gonadotropins in combination with GnRH
analogues. In the patients with "poor ovarian response" diagnosis, the limited number of
obtained oocytes remains the main obstacle in optimizing the live birth rates. The objective
of present study is to evaluate a new procedure to increase a cohort of the growing antral
follicles and consequently the number of retrieved oocytes after hormonal stimulation by
gonadotropins in combination with GnRH antagonist. In present study, eligible patients with
diagnosis poor ovarian responder based on the Bologna criteria are included. Ovarian
stimulation procedure will be performed by antagonist protocol. All the patients will be
received two tablets daily of Estradiol valerate (Estraval®, 2 mg, Aburaihan Co., Tehran,
Iran) starting a week after LH surge until menses. The hormonal evaluation (serum LH and FSH)
and basic vaginal ultrasound will be performed before the starting ovarian stimulation on the
2th or 3th day of the menstrual cycle. On this day, the block randomization method will be
designed to randomize allocation of patients into groups with blocks of size 4.
In the Group A: treatment with GnRH antagonists (Cetrotide®, 0.25 mg cetrorelix acetate,
Serono, Inc) will be started on the 2th or 3th day of the menstrual cycle and continues until
the ninth day. Then, the ovarian stimulation with gonadotropin 300 IU recombinant FSH (Gonal
- F®, Serono Laboratories Ltd, Geneva, Switzerland) and 150 IU of hMG (Menopur®; Ferring)
will be started from ninth day of menstrual cycle until the day of hCG administration. The
monitoring of ovarian stimulation will be done every other day by vaginal ultrasound and
whenever at least 1 to 3 follicles larger than 13 mm are observed, the antagonist injection
(Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc) will be started again to prevent
premature LH surge and continues until the prescription of hCG. When at least two follicles
greater than 17 to 18 mm is seen, two pre-filled syringes of recombinant human chorionic
gonadotropin (rhCG) (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be administered. The
patients will undergo puncture operation 32-34 hours after hCG injection.
In the control group (B), as conventional antagonist procedure, the ovarian stimulation with
gonadotropin 300 IU recombinant FSH (Gonal - F®, Serono Laboratories Ltd, Geneva,
Switzerland) and 150 IU of hMG ( Menopur®; Ferring ) will be started from on the 2th or 3th
day of the menstrual cycle. The monitoring of ovarian stimulation will be done every other
day by vaginal ultrasound and whenever at least 1 to 3 follicles larger than 13 mm are
observed, the antagonist injection (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc) will
be started again to prevent premature LH surge and continues until the prescription of rhCG.
32-34 hours after the rhCG injection, the ovum pick up will be performed and subsequently
intracytoplasmic sperm injection (ICSI) /in-vitro fertilization (IVF) will be done for all
the patients.
