To study the effect of laparoscopic ovarian drilling (LOD) versus step-up gonadotropin therapy on follicular response in infertile anovulatory PCOS women resistant to sequential Letrozole + HMG (Human Menopausal Gonadotropin) based ovulation induction (OVI) cycles DESIGN: Open-labelled, pilot, randomised controlled trial SUBJECTS: Infertile anovulatory PCOS women (diagnosed according to modified Rotterdam criteria) resistant to sequential letrozole 5mg + HMG based OVI cycle (no dominant follicle >10mm after 14 days of stimulation). Other inclusion criteria were: age 19-38 years; BMI ≤ 35kg/m2; patent fallopian tubes documented on either hysterosalpingography/saline infusion sonography or laparoscopy; AMH levels > 6ng/ml. Exclusion criteria were AMH ≤ 6 ng/ml; moderate to severe male factor infertility and endometriosis. Participants in Group 1 (N=35) underwent LOD following which OVI cycles were started with Letrozole 5mg from the following menses. Gonadotropin were added in sequential manner if required as per the follicular response. Women in Group 2 (N=35) were administered injection HMG (75 IU) from day 2 of menses and dose increments were done from day 9 onwards as per response. Primary outcome was follicular response (dominant follicle >16mm). Secondary objectives were gonadotropin requirement per cycle, duration of stimulation, time to conception (months), clinical pregnancy rate and ongoing pregnancy rate (>12 week). The study also compared the effect of LOD on hormonal parameters (AMH, serum testosterone) and metabolic parameters (fasting insulin, fasting blood glucose, lipid profile, HOMA-IR) after 1-2 months of procedure. Majority of the study participants (82.85%) belonged to PCOS phenotype A. The baseline clinical, hormonal and metabolic characteristics and phenotype distribution were comparable in both the groups. The follicular response was significantly higher in LOD group (93.25%; 83/89) as compared to step-up gonadotropin group (28.20%; 11/39) (P<0.001). With 4 spontaneous conceptions, the median time to conception in LOD group was 3.9 (0-8.4) months. The clinical pregnancy rate per patient was significantly higher in LOD group 54.28% (19/35) as compared to step-up gonadotropin group 8.57% (3/35) (P<0.001). The ongoing pregnancy rate in LOD group was 45.71% (16/35) versus 0% (0/35) in gonadotropin group (P<0.001) respectively. There was significant fall in the AMH levels from 15.2 ± 2.7 ng/ml to 10.2 ± 4.4 ng/ml after LOD. Though statistically insignificant, the levels of LH/FSH ratio, testosterone, fasting insulin, fasting glucose and HOMA-IR levels were also lowered. Laparoscopic ovarian drilling (LOD) significantly improves the follicular response as compared to step-up gonadotropin based ovulation induction and results in higher clinical and ongoing pregnancy rate along with significant reduction in gonadotropin requirement. The procedure may be considered for PCOS women resistant to sequential letrozole + HMG-based ovulation induction especially phenotype A with high AMH and high follicle number per ovary (FNPO).
Bhavana et al. (Fri,) studied this question.