Infertility Clinical Trial
Official title:
Evaluation of Outcome of Double Stimulation and Egg Collection in the Same IVF/ ICSI Cycle in Poor Ovarian Responders
This study is a prospective before & after clinical trial to investigate the efficacy of
double stimulations during both the follicular and luteal phases in patients with poor
ovarian response undergoing IVF and intracytoplasmic sperm injection (ICSI) cycles.
The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan
institute. The study is conducted according to the Declaration of Helsinki for medical
research. All participants provide informed consent after counseling for infertility
treatments and routine IVF/ICSI programs.
All the patients who diagnosed as poor ovarian responders (POR) based on the Bologna
criteria are eligible for participation in this study. In order to define the poor response
in IVF, at least two of the following three features must be present: (i) advanced maternal
age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian
reserve test (ORT). Two episodes of POR after maximal stimulation are sufficient to define a
patient as poor responder in the absence of advanced maternal age or abnormal ORT.
Stage one of treatment protocol First stimulation performs by Clomiphene citrate (Ovumid®,
Iran Hormones Company) 25 mg/day with co-treatment of Letrozole (Letrofem®, Iran Hormones
Company) 2.5 mg/day are given from cycle day 3 onwards. Letrozole is only given for 4 days
and clomiphene citrate is continuously used before the trigger day. Patients start to inject
human menopausal gonadotrophin (HMG) (Menopur®, Ferring, Switzerland) 150 IU every other day
beginning on cycle day 6. When one or two dominant follicles (18 mm in diameter) observed,
the final stage of oocyte maturation will be induced with triptorelin 100 μg (Decapeptyl®;
Ferring GmbH, Germany) follows by ibuprofen 600 mg (Ibuprofen-Najo® , Coated Tablets, Najo
Company, Iran) is used on the day of oocyte maturation triggering and the day after. After
the first oocyte retrieval, human menopausal gonadotrophin and letrozole are administrated
to stimulate follicle development, and oocyte retrieval will be carried out a second time
when dominant follicles have matured. All highest-quality embryos (including grade 1 and
grade 2, eight-cell blastomere embryos) will be cryopreserved by vitrification method on the
third day after oocyte retrieval.
Stage two of treatment protocol:
Transvaginal ultrasound evaluation performs after oocyte retrieval to determine whether to
continue the second ovarian stimulation. The criterion for continued stimulation is the
presence of at least two antral follicles 2-8 mm in diameter. A total of 225 IU HMG
(Menopur®, Ferring, Switzerland) and letrozole 2.5 mg (Letrofem®, Iran Hormones Company) is
administered daily from the day of, or the day after, oocyte retrieval. The initial second
stage follicular monitoring is conducted 5-7 days later, and then for follow up every 2-4
days, by using a transvaginal ultrasound evaluation, to record the number of developing
follicles. Letrozole administration is discontinued when the dominant follicles reached
diameters of 12 mm, given that large follicles have redundant LH and FSH receptors, and good
response to exogenous hormone stimulations. Daily administration of medroxyprogesterone
acetate 10 mg (Progestrone®, 5mg bid; Aboureihan, Iran) is added beginning on stimulation
day 12 for cases in which post-ovulation follicle size is smaller than 14 mm in diameter and
stimulation needed to continue for several more days. This performs to postpone menstruation
and avoid oocyte retrieval during menstruation, to prevent the risk of infection from the
procedure. When three dominant follicles reached diameters of 18 mm or one mature dominant
follicle exceeded 20 mm, the final stage of oocyte maturation is induced again with
triptorelin 100 μg (Decapeptyl®; Ferring GmbH, Germany) by injection. Again, ibuprofen 600
mg (Ibuprofen-Najo® , Coated Tablets, Najo Company, Iran) is used on the day of oocyte
maturation triggering and the day after. Transvaginal ultrasound-guided oocyte retrieval was
conducted 32-36 h after GnRH agonist administration. All retrieved oocytes were treated same
as in the study stage one.
Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. The mean of total number of retrieved oocytes and embryos after the present protocol were compared with the mean of total number of retrieved oocytes and embryos at previous routine cycle. ;
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