OBJECTIVE: To investigate the effect of stopping progesterone (P) support at week 5 versus week 8 on ongoing pregnancy rate after in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). DESIGN: Prospective, randomized, controlled trial. SETTING: University-affiliated infertility center. PATIENT(S): A total of 220 patients with intrauterine pregnancy demonstrated by transvaginal ultrasound after IVF/ICSI. INTERVENTION(S): Luteal phase support with micronized vaginal P was suspended at week 5 or at week 8. MAIN OUTCOME MEASURE(S): Ongoing pregnancy rate, miscarriage rate, and number of bleeding episodes. RESULT(S): Progesterone levels were similar on the day of the first pregnancy ultrasound exam (149 ± 108 vs. 167 ± 115 ng/mL). Significantly more bleeding episodes were observed in the first trimester in the group with early cessation of P supplementation (18.0 ± 2.6 vs. 7.2 ± 1.3 episodes). Miscarriage rates among singleton pregnancies were similar in the two groups (5/80 vs. 6/79). CONCLUSION(S): Vaginal P supplementation after IVF/ICSI can be safely withdrawn at 5 weeks' gestation, because cycle outcome was similar to conventional luteal phase support up to 8 weeks of pregnancy. CLINICAL TRIAL REGISTRATION NUMBER: NCT01177904.
RCT Entities:
OBJECTIVE: To investigate the effect of stopping progesterone (P) support at week 5 versus week 8 on ongoing pregnancy rate after in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). DESIGN: Prospective, randomized, controlled trial. SETTING: University-affiliated infertility center. PATIENT(S): A total of 220 patients with intrauterine pregnancy demonstrated by transvaginal ultrasound after IVF/ICSI. INTERVENTION(S): Luteal phase support with micronized vaginal P was suspended at week 5 or at week 8. MAIN OUTCOME MEASURE(S): Ongoing pregnancy rate, miscarriage rate, and number of bleeding episodes. RESULT(S): Progesterone levels were similar on the day of the first pregnancy ultrasound exam (149 ± 108 vs. 167 ± 115 ng/mL). Significantly more bleeding episodes were observed in the first trimester in the group with early cessation of P supplementation (18.0 ± 2.6 vs. 7.2 ± 1.3 episodes). Miscarriage rates among singleton pregnancies were similar in the two groups (5/80 vs. 6/79). CONCLUSION(S): Vaginal P supplementation after IVF/ICSI can be safely withdrawn at 5 weeks' gestation, because cycle outcome was similar to conventional luteal phase support up to 8 weeks of pregnancy. CLINICAL TRIAL REGISTRATION NUMBER: NCT01177904.
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