Oral dydrogesterone for luteal support in frozen-thawed embryo transfer artificial cycles: A pilot randomized controlled trial

Rashidi, Batool Hossein; Ghazizadeh, Mahya; Nejad, Ensieh Shahrokh Tehrani; Bagheri, Maryam; Gorginzadeh, Mansoureh

doi:10.1016/j.apjr.2016.10.002

Cited by 36 publications

(44 citation statements)

References 26 publications

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“…Ten studies were further examined for eligibility: one study was excluded because it compared dydrogesterone with vaginal progesterone capsules for luteal support in IUI cycles ( Khosravi et al ., 2015 ). Nine studies were included in our quantitative analysis ( Chakravarty et al ., 2005a ; Ganesh et al ., 2011 ; Patki & Pawar, 2007 ; Rashidi et al ., 2016 ; Saharkhiz et al ., 2016 ; Salehpour et al ., 2013 ; Tournaye et al ., 2017 ; Zarei et al ., 2017 ; Zargar et al ., 2016 ); four of the nine studies had groups given medication other than oral dydrogesterone and vaginal progesterone capsules: vaginal progesterone gel ( Ganesh et al ., 2011 ); intramuscular progesterone ( Rashidi et al ., 2016 ; Zargar et al ., 2016 ); dydrogesterone combined with either GnRH agonist or hCG ( Zarei et al ., 2017 ). The individuals in these groups were not included in the quantitative analysis.…”

Section: Resultsmentioning

confidence: 99%

“…One study was held in two centers ( Saharkhiz et al ., 2016 ), one in 38 different sites ( Tournaye et al ., 2017 ), and the remaining seven were carried out in single centers. Five studies were conducted in Iran ( Rashidi et al ., 2016 ; Saharkhiz et al ., 2016 ; Salehpour et al ., 2013 ; Zarei et al ., 2017 ; Zargar et al ., 2016 ), three in India ( Chakravarty et al ., 2005a ; Ganesh et al ., 2011 ; Patki & Pawar, 2007 ), and one in multiple centers in Austria, Belgium, Germany, Finland, Israel, Russia, and Spain ( Tournaye et al ., 2017 ). Despite attempts to contact the authors of all studies, additional details were collected from only one study ( Saharkhiz et al ., 2016 ).…”

Section: Resultsmentioning

confidence: 99%

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Oral dydrogesterone vs. vaginal progesterone capsules for luteal-phase support in women undergoing embryo transfer: a systematic review and meta-analysis

Mwp¹,

Npb²,

Acp³

et al. 2018

JBRA Assisted Reproduction

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ObjectiveTo identify, appraise, and summarize the evidence from randomized controlled trials (RCTs) comparing oral dydrogesterone to vaginal progesterone capsules for luteal-phase support (LPS) in women offered fresh or frozen embryo transfers following in vitro fertilization.MethodsTwo independent authors screened the literature for papers based on titles and abstracts, then selected the studies, extracted data, and assessed the risk of bias. Dydrogesterone and progesterone were compared based on risk ratios (RR) and the precision of the estimates was assessed through the 95% confidence interval (CI).ResultsAn electronic search performed on June 7, 2017 retrieved 376 records, nine of which were papers deemed eligible and included in this systematic review and quantitative analysis. Good quality evidence indicates that oral dydrogesterone provided at least similar results than vaginal progesterone capsules on live birth/ongoing pregnancy (RR=1.08, 95%CI=0.92-1.26, I2=29%, 8 RCTs, 3,386 women) and clinical pregnancy rates (RR 1.10, 95% CI 0.95 to 1.27; I2=43%; 9 RCTs; 4,061 women). Additionally, moderate quality evidence suggests there is no relevant difference on miscarriage rates (RR=0.92, 95%CI=0.68-1.26, I2=6%, 8 RCTs, 988 clinical pregnancies; the quality of the evidence was downgraded because of imprecision).ConclusionsGood quality evidence from RCTs suggest that oral dydrogesterone provides at least similar reproductive outcomes than vaginal progesterone capsules when used for LPS in women undergoing embryo transfers. Dydrogesterone is a reasonable option and the choice of either of the medications should be based on cost and side effects.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Oral dydrogesterone vs. vaginal progesterone capsules for luteal-phase support in women undergoing embryo transfer: a systematic review and meta-analysis

Mwp¹,

Npb²,

Acp³

et al. 2018

JBRA Assisted Reproduction

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“…In this study, we used dydrogesterone, which is an orally administered synthetic progestogen that has been successfully used for luteal phase support in stimulated IVF cycles over the past decade [22-24, 37, 38]. However, limited data are available about its use in artificial frozen-thawed cycles, which have different underlying endocrinological issues [39,40]. Due to its unique molecular structure, dydrogesterone has a more selective binding capacity to the natural progesterone receptor.…”

Section: Discussionmentioning

confidence: 99%

“…Although all women receive the same dose of vaginal progesterone, the uptake, absorption and metabolism of each hormone can vary among women ( [26]. One study [39] reported comparable pregnancy rates between the oral dydrogesterone and micronized vaginal progesterone groups, using equivalent doses of 40 mg and 800 mg, respectively. In line with Rashidi's research, our IVF unit administered 40 mg dydrogesterone orally.…”

Section: Discussionmentioning

confidence: 99%

Association between serum progesterone levels on the day of frozen-thawed embryo transfer and pregnancy outcomes after artificial endometrial preparation

Zhu

Huang

et al. 2020

Preprint

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Background Previous studies have examined that a range of optimal serum P level during the implantation period was associated with optimal live birth rates. However, those results obtained with vaginal or intramuscular route of progesterone administration for LPS alone. Is there a relationship between the serum progesterone (P) on the day of frozen-thawed embryo transfer (FET) with the likelihood of a live birth(LB) in artiﬁcial cycles(AC) when using a combination of oral dydrogesterone and vaginal progesterone for luteal phase support (LPS)? Methods This was a retrospective study of 3659 FET cycles with artiﬁcial endometrial preparation in a Chinese tertiary-care academic medical centre from January 2015 to February 2017. Endometrial preparation was performed using estradiol (E 2 ) valerate (Fematon-red tablets) 8 mg/d beginning on day 3 of the cycle, followed by administration of P both orally (40 mg dydrogesterone and 8 mg E 2 twice per day, Fematon-yellow tablets) and vaginally (400 mg/d; Utrogestan). The primary endpoint was LBR. The association between the serum P level on the embryo transfer day and pregnancy outcomes was evaluated by univariable and multivariable logistic regression analysis. Results Mean serum P on the day of embryo transfer was 10.30 ± 3.88 ng/ml (percentiles: 25, 7.9; 50, 9.7; 75, 12.1). The LBRs according to the serum P quartiles were as follows: Q1, 35.7%; Q2, 37.4%; Q3, 39.1%; and Q4: 38.9%. Logistic regression analysis showed that the odds of a LB were not significantly different between the low (P <7.9 ng/mL) and high (P ≥7.9 ng/mL) progesterone groups before or after adjustment (crude odds ratio [OR] = 0.89, 95% confidence interval [CI]: 0.76-1.04; adjusted OR = 0.89, 95% CI: 0.75-1.04). Conclusions The present study suggests that the serum P levels on the day of ET do not correlate with the likelihood of a LB in artiﬁcial cycles when using a combination of oral dydrogesterone and vaginal progesterone for luteal phase support. In addition, prospective, randomized, controlled, blinded trials are merited to determine the optimal dosing regimen for oral dydrogesterone in in AC-FET for LPS.

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“…A well-known, long-used oral semisynthetic progestin (dydrogesterone) has been administered orally in women requiring progesterone supplementation for many indications, since it is not degraded by gastric acidity and skips the first pass metabolism, and, therefore, has a quite high bioavailability [13] [14]. Recently numerous clinical trials have investigated the efficacy of oral dydrogesterone as luteal phase support, in women undergoing in Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) and found comparable efficacy to micronized progesterone [15]- [20]. In addition, a recent systematic review and meta-analysis found similar conclusion [21].…”

Section: Introductionmentioning

confidence: 99%

Oral Dydrogesterone versus Vaginal Micronized Progesterone in Luteal Phase Support after Controlled Ovarian Stimulation Using Long Gonadotropin-Releasing Hormone Agonist in Women Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection

Ibrahem¹

2019

OJOG

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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.

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Oral dydrogesterone for luteal support in frozen-thawed embryo transfer artificial cycles: A pilot randomized controlled trial

Cited by 36 publications

References 26 publications

Oral dydrogesterone vs. vaginal progesterone capsules for luteal-phase support in women undergoing embryo transfer: a systematic review and meta-analysis

Oral dydrogesterone vs. vaginal progesterone capsules for luteal-phase support in women undergoing embryo transfer: a systematic review and meta-analysis

Association between serum progesterone levels on the day of frozen-thawed embryo transfer and pregnancy outcomes after artificial endometrial preparation

Oral Dydrogesterone versus Vaginal Micronized Progesterone in Luteal Phase Support after Controlled Ovarian Stimulation Using Long Gonadotropin-Releasing Hormone Agonist in Women Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection

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