Introduction

Luteal phase support (LPS) is a medical treatment to improve the attainment rate of implantation and pre-embryo life thus supporting and complementing the roles of corpus luteum. Micronized vaginal progesterone (MVP) could lead to progesterone-unaffected uterine syndrome; irritating vaginal discharge and itching associated with its use. Oral medications with similar outcomes to vaginal medications would be more acceptable to women. The use of oral dydrogesterone is as effective as our current standard of care – MVP pessary.

Aim

To evaluate the pregnancy rates, adverse reactions, and medication costs of two luteal phase support regimens: oral dydrogesterone and MVP pessary in in vitro fertilization cycles.

Patient Profile

Infertile couples scheduled for in vitro fertilization and embryo transfer (IVF-ET) cycles with self or donated ovum

• Women with stimulated cycles [self-ovum] and aged between 20 and 40 years with FSH level <10 IU/l
• Women using donated ovum, <55 years of age, peri-menopausal, or menopausal

Methods

• Randomized open-label trial with participants randomly assigned to either 400 mg MVP twice daily or 10 mg dydrogesterone three times daily

Study endpoints

• Primary: Pregnancy rates
• Secondary: Tolerance, Miscarriage rates, and Medication cost

Results

• Dydrogesterone had statistically similar (p>0.05) positive pregnancy test rates fifteen days post embryo transfer (35.8% vs. 32.7%), clinical pregnancy rates at the gestational age of 6 weeks (32.1% vs. 28.8%), ongoing pregnancy rates (26.4% vs. 23.1%) and miscarriage rates at 14 weeks of gestation (9.2% vs. 9.4%) and safety profile to MVP

  Figure1: Comparison of study endpoints

  

   

• Dydrogesterone was better tolerated as vaginal itching was significantly more prevalent in the MVP arm (p=0.008)

  Conclusion

• Oral dydrogesterone and MVP pessary had similar pregnancy rates and adverse effects
• Dydrogesterone appeared to be user-friendly, safe and less expensive in cases of luteal-phase support in in vitro fertilization cycles

Reference

J Med Life. 2023 Jan;16(1):62-69