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Eyal Krispin, Eran Hadar, Rony Chen, Arnon Wiznitzer, Boris Kaplan
OBJECTIVE: We aimed to compare the efficacy of commonly available progesterone preparations for preterm birth prevention. METHODS: A retrospective cohort study of all women treated with progesterone to prevent preterm birth and delivered in a single university-affiliated tertiary medical-center. Four progesterone preparations were compared: vaginal Endometrin 100 mg twice daily, vaginal Crinone 8% gel 90 mg daily, vaginal Utrogestan 200 mg daily, and intramuscular 17α-hydroxyprogesterone caproate (17-OHPC) 250 mg weekly...
April 26, 2018: Journal of Maternal-fetal & Neonatal Medicine
Tim Child, Saoirse A Leonard, Jennifer S Evans, Amir Lass
Vaginal progesterone via capsule, gel or tablet is the most common route for luteal phase support (LPS) in Europe. Although there is a wealth of data comparing products used at other stages of assisted reproductive technology cycles, there is a lack of systematically identified evidence comparing the wide range of vaginal progesterone products. This systematic review queried the MEDLINE, Embase and Cochrane Library databases on 30 June 2016 to identify head-to-head randomized controlled trials (RCTs) comparing the efficacy or safety of vaginal progesterone preparations (Crinone, Cyclogest, Lutigest or Utrogestan Vaginal) for LPS in assisted reproductive technology cycles...
June 2018: Reproductive Biomedicine Online
Dajun Fang, Mario Moreno, Robert E Garfield, Ruben Kuon, Huimin Xia
OBJECTIVES: Progestins, notably progesterone (P4) and 17 alpha hydroxyprogesterone caproate, are presently used to treat pregnant women at risk of preterm birth. The aim of this study was to assess the optimal treatment options for progesterone (P4) to delay delivery using a sensitive bioassay for progesterone. STUDY DESIGN: Pregnant rats, known to be highly sensitive to progestins, were treated with P4, including Prochieve® (also known as Crinone® ), in various vehicles from day 13 of gestation and in late gestation, days 19 to 22, and delivery times noted...
September 2017: European Journal of Obstetrics, Gynecology, and Reproductive Biology
Guolan Wu, Junchun Chen, Xingjiang Hu, Huili Zhou, Jian Liu, Duo Lv, Lihua Wu, Jianzhong Shentu
Objective: A generic vaginal progesterone gel has recently been developed in China. Little is known about its pharmacokinetic properties in Chinese subjects. The purpose of our study was to investigate the pharmacokinetics of three forms of vaginal progesterone gel (test formulations at 4 and 8% strength vs. a reference formulation: Crinone 8%) in Chinese healthy post-menopausal women. Methods: This study consisted of two parts study. The part 1 study was a single-center, open-label, 3-period study. Twelve healthy post-menopausal women were to evaluate the safety and pharmacokinetics of 45 mg vaginal progesterone gel (Test 4%) following single dose and multiple doses administered once every other day (q...
2017: Frontiers in Pharmacology
Lucie Michnova, Jiri Dostal, Milan Kudela, Petr Hamal, Katerina Langova
BACKGROUND AND OBJECTIVE: Luteal phase physiology is distorted by in vitro fertilization (IVF) cycles using gonadotropin-releasing hormone (GnRH) agonists and antagonists, Controlled ovarian hyperstimulation leads to luteal phase defect and for this reason, luteal phase support is now an integral part of IVF/ICSI-ET programs. The support is provided by hCG, progesterone or GnRH-a. This study compared the efficiency, safety and tolerance of two vaginal micronized progesterones, Utrogestan and Crinone 8%...
March 2017: Biomedical Papers of the Medical Faculty of the University Palacký, Olomouc, Czechoslovakia
L Michnová, J Dostál, K Langová, T Rumpíková, M Kudela
OBJECTIVE: The study was focused on comparison of efficiency, safety and tolerance of vaginal use of micronized progesterone in preparations Utrogestan and Crinone 8%. DESIGN: Prospective randomized study. SETTING: Department of Gynecology and Obstetric, University Hospital, Olomouc, Faculty of Medicine and Dentistry, Palacky University, Olomouc. MATERIAL AND METHODOLOGY: Into a prospective randomized study was, after calculation of 80% of the power of the study, α = 0,05, included 111 women in age between 18-40 with a basal value FSH < 10 IU/l and a normal finding in uteral cavity...
December 0: Ceská Gynekologie
Burak Karadag, Berna Dilbaz, Deniz Karcaaltincaba, Elif Gulsah Sahin, Fedi Ercan, Yetkin Karasu, Nazan Vanlı Tonyalı
The purpose of this study is to analyse the effect of luteal-phase support on pregnancy rates in gonadotropin + intra-uterine insemination (Gn/IUI) and clomiphene citrate (CC) +IUI (CC/IUI) cycles in patients with unexplained infertility. Equal numbers of patients were recruited in two treatment arms (CC/IUI and Gn/IUI) (n = 100, n = 100, respectively). In each group, 50 patients received vaginal progesterone for 14 days (Crinone 8% vaginal gel, 90 mg per day) for luteal-phase support from the day after IUI and continued until menstruation or the 10th week of gestation if pregnant...
August 2016: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
Yang Wang, Yaqiong He, Xiaoming Zhao, Xiaowei Ji, Yan Hong, Yuan Wang, Qinling Zhu, Bin Xu, Yun Sun
UNLABELLED: To compare Crinone vaginal progesterone gel with intramuscularly injected progesterone for luteal phase support in progesterone-supplemented frozen-thawed embryo transfer (FET) cycles, a randomized prospective study of patients qualified for FET was conducted between September 2010 and January 2013 at a hospital in Shanghai, China. From the day of transformation into secretory phase endometrium (day 0), Crinone vaginal gel (90 mg/d) was administered to patients in the Gel Group, while progesterone (40 mg/d) was injected intramuscularly in patients in the Inj Group (n = 750 per group)...
2015: PloS One
Kathryn S Merriam, Kristina A Leake, Mollie Elliot, Michelle L Matthews, Rebecca S Usadi, Bradley S Hurst
Objective. To determine if sexual intercourse reduces absorption of vaginal progesterone gel in women and to determine if progesterone is absorbed by the male during intercourse. Study Design. Prospective, randomized, cross over, controlled study of 20 reproductive-aged women and their male sexual partners randomized to receive vaginal progesterone gel (Crinone 8% gel, Actavis Inc., USA) or placebo cream. Serum progesterone for both male and female partners were measured 10 hours after intercourse. One week later, subjects were crossed over to receive the opposite formulation...
2015: International Journal of Endocrinology
Vlatka Tomic, Jozo Tomic, Djurdja Zigmundovac Klaic, Miro Kasum, Krunoslav Kuna
OBJECTIVES: To compare efficacy, satisfaction and tolerability of oral dydrogesterone and micronized vaginal progesterone gel used for luteal supplementation. STUDY DESIGN: Randomized controlled trial. A total of 853 infertile women undergoing IVF/ICSI treatment in University Hospital Center "Sisters of Mercy", Zagreb, Croatia. Luteal support was provided as Crinone 8%(®) vaginal progesterone gel (90mg) administered daily, or oral dydrogesterone Duphaston(®) (2× 10mg) administered two times daily...
March 2015: European Journal of Obstetrics, Gynecology, and Reproductive Biology
Maria Campaña-Seoane, Aaron Peleteiro, Reyes Laguna, Francisco J Otero-Espinar
The aim of this study is to propose that mucoadhesive vaginal emulsions can be able to resist the clearance effect of vaginal fluid and to have an effective control release of progesterone. With this goal, silicon derivative, cyclomethicone pentamer, was selected as the bioadhesive and water resistant material. In order to obtain a system which is insensitive to the dilution of aqueous fluids, water in silicone (W/S) emulsions were prepared and different proportions of cyclomethicone as well as 8% or 15% w/w of progesterone were employed...
December 30, 2014: International Journal of Pharmaceutics
Fatma Kutlusoy, Ismail Guler, Mehmet Erdem, Ahmet Erdem, Nuray Bozkurt, Ebru H Biberoglu, Kutay O Biberoglu
In this study, our objective was to determine the effect of adding estradiol hemihydrate (E2) to progestin (P) for luteal phase support on pregnancy outcome in in vitro fertilization (IVF) cycles with poor response to gonadotropins. Ninety-five women with poor ovarian response who underwent controlled ovarian hyperstimulation (COH) with gonadotropin releasing hormone (GnRH) agonist or GnRH antagonist plus gonadotropin protocol for IVF were prospectively randomized into three groups of luteal phase support after oocyte retrieval...
May 2014: Gynecological Endocrinology
Luke Y Ying, Ying Ying, James Mayer, Anthony N Imudia, Shayne M Plosker
OBJECTIVES: To study the effect of embryo transfer (ET) catheter contact with intravaginal progesterone preparations on mouse embryo development. STUDY DESIGN: In a simulated ET model, ET catheters were loaded with culture medium, placed in contact with intravaginal progesterone gel (Crinone 8%) or micronized progesterone intravaginal inserts (Endometrin 100 mg), and the intracatheter culture medium flushed. Embryos were cultured in the flushed culture medium at variable dilutions for variable lengths of time...
August 2014: Reproductive Sciences
Su-Kyoung Kwon, Chung-Hoon Kim, Kyung-Hee Lee, Il Kyung Jeon, Jun-Woo Ahn, Sung-Hoon Kim, Hee-Dong Chae, Byung-Moon Kang
OBJECTIVE: To evaluate the effect of the addition of estradiol to luteal progesterone supplementation in GnRH antagonist cycles for infertile patients undergoing IVF/ICSI. METHODS: One hundred and ten infertile patients, aged 28 to 39 years, were recruited for this prospective randomized study. They were randomly assigned to receive vaginal progesterone gel (Crinone) along with 4 mg estradiol valerate (group 1, n=55) or only Crinone (group 2, n=55) for luteal support...
September 2013: Clinical and Experimental Reproductive Medicine
Gillian Lockwood, Georg Griesinger, Barbara Cometti
OBJECTIVE: To compare the safety, efficacy, and tolerability of subcutaneous progesterone (Prolutex, 25 mg; IBSA Institut Biochimique SA) with vaginal progesterone gel (Crinone, 8%; Merck Serono) for luteal phase support (LPS) in assisted reproduction technologies (ART) patients. DESIGN: Prospective, open-label, randomized, controlled, parallel-group, multicenter, two-arm, noninferiority study. SETTING: Thirteen European fertility clinics...
January 2014: Fertility and Sterility
Birgit Alsbjerg, Nikolaos P Polyzos, Helle Olesen Elbaek, Betina Boel Povlsen, Claus Yding Andersen, Peter Humaidan
The aim of this study was to evaluate the reproductive outcome in patients receiving frozen-thawed embryo transfer before and after doubling of the vaginal progesterone gel supplementation. The study was a retrospective study performed in The Fertility Clinic, Skive Regional Hospital, Denmark. A total of 346 infertility patients with oligoamenorrhoea undergoing frozen-thawed embryo transfer after priming with oestradiol and vaginal progesterone gel were included. The vaginal progesterone dose was changed from 90 mg (Crinone) once a day to twice a day and the reproductive outcome during the two periods was compared...
February 2013: Reproductive Biomedicine Online
Christina Bergh, Svend Lindenberg
UNLABELLED: SUMMARY QUESTION: Is vaginal progesterone gel equivalent to vaginal micronized progesterone tablets concerning ongoing pregnancy rate and superior concerning patient convenience when used for luteal support after IVF/ICSI? SUMMARY ANSWER: Equivalence of treatments in terms of ongoing live intrauterine pregnancy rate has not been demonstrated; the 95% confidence interval (CI) for the difference in ongoing pregnancy rate (-8.2 to 0.1%) did not lie entirely within the pre-specified equivalence interval -7 to 7%...
December 2012: Human Reproduction
Daniel J Kaser, Elizabeth S Ginsburg, Stacey A Missmer, Katharine F Correia, Catherine Racowsky
OBJECTIVE: To compare outcomes after intramuscular progesterone (IMP) or 8% Crinone vaginal gel for luteal support for day 3 cryopreserved embryo transfer (CET). DESIGN: Retrospective cohort study with multivariable analysis. SETTING: Academic medical center. PATIENT(S): All autologous and donor egg in vitro fertilization and intracytoplasmic sperm injection patients who had a day 3 CET from January 1, 2008, to April 30, 2011, with luteal support using 25-50 mg/d IMP or 8% Crinone twice daily, initiated 3 days before the CET...
December 2012: Fertility and Sterility
Brian M Berger, James A Phillips
PURPOSE: Compare outcomes with vaginal gel versus intramuscular progesterone replacement in donor oocyte recipients. METHODS: A single-center retrospective analysis (January 2004-December 2006) evaluated pregnancy outcomes (serum human chorionic gonadotropin, implantation, clinical pregnancy, delivery, total pregnancy loss rates) for 225 recipients of embryos from donor (aged <32 years) oocytes. Vaginal progesterone gel (Crinone® 8%; 90 mg twice daily; n = 105) or intramuscular progesterone (50 mg once daily; n = 120) was started the afternoon of oocyte retrieval and continued until a negative pregnancy test or 10 weeks' gestation...
March 2012: Journal of Assisted Reproduction and Genetics
Kaylen M Silverberg, Thomas C Vaughn, Lisa J Hansard, Natalie Z Burger, Tamara Minter
OBJECTIVE: To compare the efficacy of intravaginal and IMP for luteal phase support in IVF cycles. DESIGN: Prospective trial. SETTING: Tertiary care private practice. PATIENT(S): Women 25-44 years old with infertility necessitating treatment with IVF. From April 1, 2008-April 1, 2009, 511 consecutive patients were enrolled; 474 completed participation, and 37 were excluded for no autologous ET (freeze all, donor recipients, failed fertilization/cleavage)...
February 2012: Fertility and Sterility
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