Ovarian Stimulation Clinical Trial
Official title:
GnRH Antagonist /Letrozole Versus Microdose GnRH Agonist Flare Protocol in Poor Responders Undergoing in Vitro Fertilization
Failure to respond to controlled ovarian hyperstimulation (COH) is still a major concern in
assisted reproduction and there is no consensus on the ovarian stimulation choice regime for
poor responders.
Aim: To evaluate and compare the efficacy of a microdose GnRH agonist flare (MF) and a GnRH
antagonist/letrozole (A/L) protocols in poor responders undergoing in vitro fertilization
(IVF).
Methods: One hundred eighty poor responder patients will be randomized to an ovarian
stimulation protocol with either a MF or a letrozole and high dose FSH/hMG and flexible GnRH
antagonist protocol.
All women receive 21 days of an oral contraceptive. A MF protocol will be used for ovarian
stimulation in 90 patients. Three days after the last pill, a GnRH-agonist buserelin
(Suprefact, Aventis Pharma, Frankfurt, Germany) 50 µg SC twice daily will be initiated and
two days after that, recombinant FSH (Gonal-F, Serono, Aubonne, Switzerland) or hMG
(Merional, IBSA, Lugano, Switzerland) 300-450 IU/day will be administered. Ninetyty patients
will be assigned to an A/L protocol. After oral contraceptive withdrawal bleeding on day 3
of cycle, recombinant FSH or hMG 300-450 IU/day will be initiated and letrozole (Femara,
Novartis, East Hanover, NJ) 5 mg/day will be administered for 5 days. When the dominant
follicle reached 14 mm in mean diameter, ganirelix acetate (Antagon, Organon, West Orange,
NJ) 0.25 mg SC daily will be started.
Patients weill be monitored by serial vaginal ultrasonography and measurement of serum E2
level. When at least two follicles with a mean diameter of 18 mm will be achieved hCG
(Pregnyl, Organon, Oss, the Netherlands) 10000 IU will be administered. Cycle cancellation
will be considered when fewer than two follicles with normal growth pattern weill be noted.
Oocyte retrieval will be performed 34-36 hours after hCG administration. Conventional IVF or
intracytoplasmic sperm injection (ICSI) will be performed as appropriate. Embryos with 4-6
equally sized blastomers on day 2 with ≤ 20% fragmentation and no multinucleation will be
considered top quality embryos. Embryos with 2-6 equally or unequally blastomers with ≤20%
fragmentation and no multinucleation will be considered good quality embryos. Embryos will
be transferred on day 2 or 3 under ultrasound guidance, with a C.C.D. embryo transfer
catheter ( Laboratoire C.C.D., Paris, France). Luteal support with progesterone in oil
(Progesterone, Aburaihan Co., Tehran, Iran) 100 mg daily IM will be started on the day of
oocyte retrieval.
Serum β-hCG level will be measured 14 days after embryo transfer and a transvaginal
ultrasonography will be performed 3 weeks after positive β-hCG for documentation of
gestational sac and fetal heart activity. Clinical pregnancy will be considered as the
presence of a gestational sac with fetal heart activity.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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