Polycystic Ovarian Syndrome Clinical Trial
Official title:
Comparison Between the Role of Follicular Output Rate and Preovulatory Count in the Prediction of Pregnancy in Women With Polycystic Ovarian Syndrome Undergoing Intra Cytoplasmic Sperm Injection (ICSI)
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 FSI and
preovulatory count which are calculated by observing routine measurements during the
IVF/ICSI procedure.
300 women with polycystic ovarian syndrome (PCOS) who are decided to be treated with ICSI.
will be subjected to full history taking and clinical examination. 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 follicle stimulating
hormone (FSH) 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. Follicular output rate (FORT) will be
calculated as: (FSI =PFC*10000/AFC*Total dose of FSH).
FORT correlation to pregnancy will be compared to that of the preovulatory count number
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 FSI and
preovulatory count which are calculated by observing routine measurements during the
IVF/ICSI procedure.
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.
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. FSH (Fostimon ®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.
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. Pregnancy will be defined as
the appearance of an intrauterine gestational sac by vaginal ultrasound 5 weeks after embryo
transfer.
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