A randomised control trial on oral dydrogesterone versus micronized vaginal progesterone pessary for luteal phase support in in vitro fertilization cycles
Authors: Ikechebelu Joseph Ifeanyichukwu ,   Department of Obstetrics and Gynaecology, Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Awka, Nigeria,   Life Fertility Centre, Life International Hospital, Awka, Nigeria,   Institute of Maternal and Child Health, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu, Nigeria,   * Corresponding Author: Joseph Ifeanyichukwu Ikechebelu, Department of Obstetrics and Gynaecology, Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Awka, Nigeria. Institute of Maternal and Child Health, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu, Nigeria. E-mail: ji.ikechebelu@unizik.edu.ng, Dim Cyril Chukwudi ,   Institute of Maternal and Child Health, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu, Nigeria,   Department of Obstetrics and Gynaecology, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu, Nigeria, Eleje George Uchenna ,   Department of Obstetrics and Gynaecology, Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Awka, Nigeria,   Institute of Maternal and Child Health, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu, Nigeria, Joe-Ikechebelu Ngozi ,   Life Fertility Centre, Life International Hospital, Awka, Nigeria,   Department of Community Medicine & Primary Health Care, College of Medicine, Chukwuemeka Odumegwu Ojukwu University, Awka, Nigeria, Okpala Boniface Chukwuneme ,   Department of Obstetrics and Gynaecology, Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Awka, Nigeria,   Life Fertility Centre, Life International Hospital, Awka, Nigeria, Okam Princeston Chukwuemeka ,   Life Fertility Centre, Life International Hospital, Awka, Nigeria,   Department of Pharmacology & Therapeutics, Faculty of Basic Clinical Sciences, College of Health Sciences, Nnamdi Azikiwe University, Awka, Nigeria
Published: May 2023

This study aimed to evaluate the pregnancy rates, adverse reactions, and medication costs of two luteal phase support regimens: oral dydrogesterone and micronized vaginal progesterone (MVP) pessary in in vitro fertilization cycles. A randomized open-label trial with participants randomly assigned to either 400 mg MVP twice daily or 10 mg dydrogesterone three times daily. The primary endpoints were pregnancy rates, and the secondary endpoints included tolerance, miscarriage rates, and medication cost. Per-protocol principle analysis was performed. The baseline characteristics of the 162 participants were similar. 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. Dydrogesterone was better tolerated as vaginal itching was significantly more prevalent in the MVP arm (p=0.008). Dydrogesterone is significantly less expensive than MVP pessary. Oral dydrogesterone and MVP pessary had similar pregnancy rates and adverse effects. Dydrogesterone appears more user-friendly and less expensive in cases of luteal-phase support in in vitro fertilization cycles.