Infertility Clinical Trial
Official title:
Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation by Using Recombinant Luteinizing Hormone (rLH) and Recombinant Follicle Stimulating Hormone (rFSH) in Patients With Hypogonadotropic Hypogonadism
We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for group B. Finally Assisted Reproductive Technology (ART) results are compared between the two groups.
In this single blind randomized clinical trial, 90 women with a clinical history of
hypogonadotrophic hypogonadism who stopped any treatment with gonadotrophins >1 month before
study, with a negative progesterone challenge test, low serum gonadotrophins (Luteinizing
Hormone (LH) and Follicle Stimulating Hormone (FSH) less than 5.0 IU/l) and oestradiol (less
than 100 pg/ml) and normal serum concentrations of thyroid stimulating hormone (TSH),
testosterone and prolactin within 6 months before the start of treatment are studied in the
Royan Institute. Other causes of infertility are excluded from the study. All patients
receive treatment with recombinant follicle stimulating hormone (Gonal-F) and recombinant
luteinizing hormone (Luveris). When at least one follicle reaches 14 mm in diameter, 4mg/day
oestradiol is administered and patients are randomly divided into two groups: Luveris alone
(intervention group) and continued treatment with both drugs Gonal-F and Luveris (control
group). When at least one follicle detects a mean diameter of ≥18 mm and serum estradiol
level reaches 500-2000 pg/ml, ovarian stimulation is stopped and injection of 10000 IU Human
Chorionic Gonadotrophin (hCG) is administrated.
At the end, the number and size of ovarian follicles, endometrial thickness on the day of
injection of Human Chorionic Gonadotrophin (hCG), the number of oocytes retrieved, the
number of good quality embryos, chemical and clinical pregnancy rate, fertilization rate and
implantation rate will be compared between the two groups.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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