The addition of gonadotrophin releasing hormone agonist to routine luteal phase support in intracytoplasmic sperm injection and embryo transfer cycles: a randomized clinical trial.

OBJECTIVES: To determine the effects of addition of different dosages of gonadotrophin releasing hormone agonist (GnRH-a) to routine luteal phase support (LPS) on implantation and pregnancy rates.

STUDY DESIGN: Three hundred infertile couples who were treated by intracytoplasmic sperm injection and embryo transfer (ICSI-ET) following controlled ovarian stimulation (COS) with long luteal GnRH agonist protocol were enrolled. All women received 600 mg/day vaginal micronized progesterone plus 4 mg 17β estradiol for LPS starting from the day of oocyte retrieval. Patients (n=300) were randomized into three treatment groups. Group A (n=100) received leuprolide acetate 1 mg s.c. injection 3 days after ET in addition to routine LPS. Group B (n=100) received two sequential doses of leuprolide acetate 1 mg s.c. injections 3 and 6 days after ET in addition to routine LPS. Control group (n=100) received only the routine LPS.

RESULTS: A total of 279 patients completed the study. The groups were comparable in terms of baseline demographic parameters including age, duration of infertility and day 3 levels of FSH and estradiol. The cycle parameters of the groups were also comparable regarding the E2 level on day of hCG, number of retrieved oocytes, number of day 3 embryos, number of embryos transferred, and endometrial thickness on both days of OPU and ET. The implantation rates were similar in between the Groups A, B, and control group (20.7% and 25.8% vs. 13.3%, respectively; P=.099). The clinical pregnancy rates and miscarriage rates were similar in between the groups. The ongoing pregnancy rates were 27.4% in control group, 36% in Group A and 42.9% in Group B (P=.093). The OHSS rates were comparable in between the groups. The multiple pregnancy rates were significantly higher in Groups A and B than in control group (12% and 17.9% vs. 4.2%, respectively; P=.014).

CONCLUSIONS: The implantation, clinical pregnancy and ongoing pregnancy and multiple pregnancy rates seem to be increased with the addition of GnRH-a to routine luteal phase support.