Lotus I: A Phase III randomized controlled trial of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization, with focus on the Russian subpopulation

Сухих, Г. Т.; Баранов, И.И.; Мельниченко, Г. А.; Bashmakova, Bashmakova N.V.; Blockeel, Christophe; Griesinger, G.; Lomakina, Anna A.; Pexman-Fieth, Claire

doi:10.18565/aig.2017.7.75-95

Cited by 5 publications

(3 citation statements)

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“…As an extension to Lotus I, a prespecified subgroup analysis was conducted on the large Russian subpopulation from the study, which represented approximately 20% of the overall population [27]. In the Russian subpopulation, oral dydrogesterone had a similar efficacy to that of MVP capsules for the primary endpoint of fetal heartbeats at 12 weeks of gestation [27], which was consistent with findings from the overall population of Lotus I [25].…”

Section: Introductionsupporting

confidence: 67%

A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation

Yang

Griesinger

Wang

et al. 2019

Gynecological Endocrinology

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Lotus II, a randomized, open-label, multicenter, international study compared the efficacy and safety of oral dydrogesterone versus micronized vaginal progesterone (MVP) gel for luteal support in IVF. A prespecified subgroup analysis was performed on 239 Chinese mainland subjects from the overall study population (n ¼ 1034), who were randomized to oral dydrogesterone 30 mg or 8% MVP gel 90 mg daily from the day of oocyte retrieval until 12 weeks of gestation. The aim was to demonstrate non-inferiority of oral dydrogesterone to MVP gel, assessed by the presence of a fetal heartbeat at 12 weeks of gestation. In the Chinese mainland subpopulation, there was a numerical difference of 9.4% in favor of oral dydrogesterone, with ongoing pregnancy rates at 12 weeks of gestation of 61.4% and 51.9% in the oral dydrogesterone and MVP gel groups, respectively (adjusted difference, 9.4%; 95% CI: À3.4 to 22.1); in the overall population, these were 38.7% and 35%, respectively (adjusted difference, 3.7%; 95% CI: À2.3 to 9.7). In both the Chinese mainland subpopulation and the overall population, dydrogesterone had similar efficacy and safety to MVP gel. With convenient oral administration, dydrogesterone has potential to transform luteal support treatment.

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Section: Introductionsupporting

confidence: 67%

A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation

Yang

Griesinger

Wang

et al. 2019

Gynecological Endocrinology

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“…In Lotus I and Lotus II studies, vaginal progesterone and oral progesterone were compared. Lotus I is a randomized, multicenter controlled phase III clinical trial that provides evidence that oral dydrogesterone is as effective as current treatments in luteal phase support for women undergoing IVF (12,13). In this study, 1,031 patients undergoing IVF or intracytoplasmic sperm injection with a fresh single or double embryo transfer after controlled ovarian stimulation were randomized to one of the two treatment arms on the day of oocyte retrieval.…”

Section: Discussionmentioning

confidence: 99%

Intracytoplasmic Sperm Injection: Clinical Result Comparison of Oral Dydrogesterone and Micronized Vaginal Progesterone Gel Use for Luteal Phase Support in Embryo Transfer Cycles

EREN

Görkemli²

2022

Preprint

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Objective: The aim of this study was to prospectively compare the effects of oral dydrogesterone and micronized vaginal progesterone (MVP) gel for luteal phase support on the pregnancy outcomes of intracytoplasmic sperm injection (ICSI) and embryo transfer (ET) cycles with controlled ovarian hyperstimulation using gonadotropin-releasing hormone in antagonists protocol.Materials and Methods: Women with infertility who attended the gynecology and obstetrics department of Meram Medical Faculty Hospital between January 2017 and January 2021 were evaluated. For the purpose of this research study, 301 patients who underwent ICSI-ET were divided into two groups. Micronized vaginal progesterone (Crinone 8% 90 mg gel with 1 time daily) was administered to 147 patients in the first group; and oral dydrogesterone (Duphaston 10 mg with 3 time daily), to 154 patients in the second group from the day of oocyte pick-up. On the twelfth day post-transfer , the ß-hCG and serum progesterone levels were measured, and the results were evaluated. A β-hCG value of ≥ 20 mIU/mL was considered to be a positive result. The rates of biochemical pregnancy, clinical abortion, clinical pregnancy, and ongoing pregnancy were compared between the two groups.Results: Among the women who underwent ICSI-ET, those who received vaginal progesterone gel and oral dydrogesterone on the day of oocyte retrieval showed similar serum progesterone levels and β-hCG positivity, biochemical pregnancy, clinical abortion, clinical pregnancy, and ongoing pregnancy rates. In terms of side effect profile, vaginal discharge and irritation complaints were found to be significantly lower in the oral progesterone group.Conclusion: The clinical results obtained from the patients who were given vaginal progesterone and oral dydrogesterone supplementation were similar. Oral progesterone support is an effective method that is more easily tolerated by patients and can be safely used for luteal phase support.

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“…Malformation rates which are associated with a drug can't be calculated using pharmacovigilance data and the low number of reported cases, few occurring within controlled studies in relation to the estimated number of pregnancies exposed suggests a relative teratogenic risk of D is very unlikely. Also, the kinds of defects attributed to D were very diverse, not having any pattern of abnormalities [31]. In the LOTUS 1 Trial, there was a recording of child health at birth for the total maternal population and 6months after birth in a subset of 216 patients, that were treated in Russia.…”

Section: Fetal Safetymentioning

confidence: 99%

Luteal Phase Support using Oral Dydrogesterone-a Prospective Treatment for Future Replacing Micronized Vaginal Progesterone

Kaur¹

2018

OAJRSD

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Although micronized vaginal progesterone is the accepted norm for use in luteal phase support (LPS) in controlled ovarian stimulation (COS) that is used for in vitro fertilization (IVF) cycles, recently importance of oral Dydrogesterone has got the importance in lieu of its oral availability, cheap, no cumbersome side effects and no definitive newer fetal side effects. After the LOTUS 1 trial with a multicenter double placebo, double dummy design it has proved an equal efficacy if not superiority of oral D, over micronized vaginal progesterone and it seems D might soon become the standard of care for LPS in conventional IVF cycles besides its routine indication for recurrent abortions.

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Lotus I: A Phase III randomized controlled trial of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization, with focus on the Russian subpopulation

Cited by 5 publications

References 0 publications

A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation

A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation

Intracytoplasmic Sperm Injection: Clinical Result Comparison of Oral Dydrogesterone and Micronized Vaginal Progesterone Gel Use for Luteal Phase Support in Embryo Transfer Cycles

Luteal Phase Support using Oral Dydrogesterone-a Prospective Treatment for Future Replacing Micronized Vaginal Progesterone

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