摘要
Background:?Luteal phase support is indicated after Controlled Ovarian Stimulation (COS) using Long Gonadotropin-Releasing Hormone Agonist (GnRHa) protocol in Women undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI). Progesterone is widely used for this indication. Objective: The objective of the current trial is to compare both efficacy and safety of oral dydrogesterone and vaginal micronized progesterone in luteal phase support in women undergoing IVF/ICSI using the long GnRHa protocol. Methods: This open-label randomized controlled study conducted at a private fertility and IVF center in Zagazig, Egypt, during the interval between April 2016 and August 2019. The study included women planned to undergo IVF/ICSI for either male factor infertility, tubal factor infertility, or unexplained infertility. Women with pelvic endometriosis, known reduced ovarian reserve, and women who were known to have poor or high response to ovarian stimulation, as well as women who were stimulated using non-long GnRHa protocol were not included. After embryo transfer, eligible women were randomly allocated into one of the two groups: group I, included women who received oral dydrogesterone 10 mg three times per day;and group II, included women who received vaginal micronized progesterone 400 mg twice per day. The primary outcome was live birth rate. The principal secondary outcome was women satisfaction. Results: Five hundred sixty four women were recruited and randomly allocated into two groups: group I [Oral Dydrogesterone Group] (n = 284), and group II [Vaginal Progesterone Group] (n = 280). Live birth rates [72 (25.4%) vs 69 (24.6%), respectively, RR 1.03, 95% CI (0.77 to 1.37)], ongoing pregnancy rates [79 (27.8%) vs 81 (28.9%), respectively, RR 0.96, 95% CI (0.74 to 1.25)], clinical pregnancy rates [97 (34.2%) vs 95 (33.9%), respectively, RR 1.01, 95% CI (0.80 to 1.27)] and miscarriage rates (per clinical pregnancy) [18 (18.6%) vs 14 (14.7%), respectively, RR 1.26, 95% CI (0.66 to 2.38)] were all comparable in both groups. The rates of vaginal burning [4 (1.4%) vs 32 (11.4%), respectively, RR 0.12, 95% CI (0.04 to 0.34)], vaginal bleeding [9 (3.2%) vs 26 (9.3%), respectively, RR 0.34, 95% CI (0.16 to 0.72)] and overall dissatisfaction [15 (5.3%) vs 68 (24.3%), respectively, RR 0.22, 95% CI (0.13 to 0.37)] were significantly lower among women of group I when compared to women of group II. Conclusion: In conclusion, when compared to vaginal micronized progesterone, oral dydrogesterone seems to be associated with comparable live birth, ongoing pregnancy and clinical pregnancy rates, and significantly lower dissatisfaction and side effects rates, when given as luteal phase support in normal responding women undergoing IVF/ICSI using the long GnRHa protocol.
Background:?Luteal phase support is indicated after Controlled Ovarian Stimulation (COS) using Long Gonadotropin-Releasing Hormone Agonist (GnRHa) protocol in Women undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI). Progesterone is widely used for this indication. Objective: The objective of the current trial is to compare both efficacy and safety of oral dydrogesterone and vaginal micronized progesterone in luteal phase support in women undergoing IVF/ICSI using the long GnRHa protocol. Methods: This open-label randomized controlled study conducted at a private fertility and IVF center in Zagazig, Egypt, during the interval between April 2016 and August 2019. The study included women planned to undergo IVF/ICSI for either male factor infertility, tubal factor infertility, or unexplained infertility. Women with pelvic endometriosis, known reduced ovarian reserve, and women who were known to have poor or high response to ovarian stimulation, as well as women who were stimulated using non-long GnRHa protocol were not included. After embryo transfer, eligible women were randomly allocated into one of the two groups: group I, included women who received oral dydrogesterone 10 mg three times per day;and group II, included women who received vaginal micronized progesterone 400 mg twice per day. The primary outcome was live birth rate. The principal secondary outcome was women satisfaction. Results: Five hundred sixty four women were recruited and randomly allocated into two groups: group I [Oral Dydrogesterone Group] (n = 284), and group II [Vaginal Progesterone Group] (n = 280). Live birth rates [72 (25.4%) vs 69 (24.6%), respectively, RR 1.03, 95% CI (0.77 to 1.37)], ongoing pregnancy rates [79 (27.8%) vs 81 (28.9%), respectively, RR 0.96, 95% CI (0.74 to 1.25)], clinical pregnancy rates [97 (34.2%) vs 95 (33.9%), respectively, RR 1.01, 95% CI (0.80 to 1.27)] and miscarriage rates (per clinical pregnancy) [18 (18.6%) vs 14 (14.7%), respectively, RR 1.26, 95% CI (0.66 to 2.38)] were all comparable in both groups. The rates of vaginal burning [4 (1.4%) vs 32 (11.4%), respectively, RR 0.12, 95% CI (0.04 to 0.34)], vaginal bleeding [9 (3.2%) vs 26 (9.3%), respectively, RR 0.34, 95% CI (0.16 to 0.72)] and overall dissatisfaction [15 (5.3%) vs 68 (24.3%), respectively, RR 0.22, 95% CI (0.13 to 0.37)] were significantly lower among women of group I when compared to women of group II. Conclusion: In conclusion, when compared to vaginal micronized progesterone, oral dydrogesterone seems to be associated with comparable live birth, ongoing pregnancy and clinical pregnancy rates, and significantly lower dissatisfaction and side effects rates, when given as luteal phase support in normal responding women undergoing IVF/ICSI using the long GnRHa protocol.
