Subfertility Clinical Trial
Official title:
Role of Follicular Output Rate in the Prediction of in Vitro Fertilization and Intracytoplasmic Sperm Injection Outcome in Women With Unexplained Infertility
300 women with unexplained infertility who are already decided to be treated with ICSI will
be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre.
On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed
and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC
will be defined as the number of follicles measuring 3-10mm.
All patients will have standard pituitary down-regulation followed by (Human menopausal
gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG)
administration. On the day of HCG administration, ovarian ultrasound scan will be performed
using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC)
is defined as number of follicles measuring≥16mm. FORT will be calculated as: (PFC) *
100/AFC.
Our study is observational, we are observing data from routine measurements during IVF/ICSI.
Our study does not assess IVF/ICSI as an intervention, we are evaluating the role of FORT
which is calculated by observing routine measurements during the IVF/ICSI procedure.
300 women with unexplained infertility who are already decided to be treated with ICSI will
be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre.
All women fulfilling the inclusion criteria will be invited to participate in the study. A
written informed consent will be taken and only women signing the consent will be included
in the study. Patients included in the study will be subjected to full history taking and
clinical examination including general, abdominal and gynecological examination. This will
be followed by a vaginal ultrasound scan to assess uterus, ovaries and any pelvic masses.
All women will go through the usual IVF/ICSI procedure explained below, our aim is to
observe the antral follicle count, the pre-ovulatory count and calculate the FORT then
correlating this with pregnancy.
On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed
and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC
will be defined as the number of follicles measuring 3-10mm.
All patients will have standard pituitary down-regulation protocol with GnRHa (Triptorelin
0.1mg, Decapeptyl® Ferring, Germany) day 7 after ovulation of previous cycle or on day 21 of
the oral contraceptive cycles. GnRHa will be continued for 2 weeks. Human menopausal
gonadotrophin(HMG) (Merional ®IBSA) 150-300 IU/day will be administered until the day of HCG
administration.
On the day of HCG administration, ovarian ultrasound scan will be performed using a
transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC) is
defined as number of follicles measuring≥16mm. FORT will be calculated as: (PFC) * 100/AFC.
FORT values will be classified into 3 categories: low, medium and high the 3 groups will be
compared regarding the clinical pregnancy rate, number of retrieved oocytes, number and
quality of embryos The procedure will be cancelled if less than 3 follicles 16-20 mm in size
are present 12 days after starting FSH despite doses reaching 450 IU. The cycle will be also
cancelled if there is risk of ovarian hyperstimulation like massive ovarian enlargement or
serum estradiol exceeds 3000pg/L Transvaginal oocyte retrieval will be performed 34-36 h
after the administration of HCG. Oocytes will be fertilized either via IVF or ICSI based on
the couple's history. Fertilization will be assessed 16-18 h after IVF or ICSI. Embryo
transfers will be performed 3 days after oocyte retrieval. No more than three embryos per
patient will be transferred; vaginal tablets containing progesterone (Prontogest® IBSA)
administered 400 mg/day as luteal support from the day of the oocyte retrieval. Clinical
pregnancy will be defined as Visualization of an intrauterine gestational sac 5 weeks after
embryo transfer.
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