Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian
hyperstimulation which may result in significant morbidity and rarely mortality as well as
significant financial and psychological distress. GnRH agonist trigger has been shown to be
effective in OHSS prevention. However, the adoption of its use has not been widely accepted
in view of concerns regarding potential impairment of implantation.

Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important
due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has
been shown that optimal conception rates is not achieved for high risk patients with peak
serum E2 < 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed
that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later
will rescue some of the corpora lutea and help improve corpora lutea function and improve
pregnancy rates.

The study will evaluate patients at high risk of OHSS development with peak serum E2 < 4,000
pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy
rates or risk of OHSS. Markers of corpus luteum function such as serum 17
hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help
elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus
luteum function.

Inclusion Criteria:

- Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome
(PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must
have > 14 follicles of over 11 mm in diameter and with peak serum E2 levels < 4,000
pg/mL on the day of trigger of oocyte maturation.

Exclusion Criteria:

- Hypothalamic dysfunction, Patients with < 14 follicles < 11 mm in diameter, peak serum
E2 levels >= 4,000 pg/mL.