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Kate Devine, Kevin S Richter, Eric A Widra, Jeffrey L McKeeby
OBJECTIVE: To assess the noninferiority of vaginal P (Endometrin) compared with daily intramuscular P for replacement in programmed vitrified-warmed blastocyst transfer cycles and to assess the noninferiority of vaginal P in combination with intramuscular progesterone every third day compared with daily intramuscular P. DESIGN: Three-arm randomized controlled noninferiority study. To enable early recognition of inferiority if present, an a priori interim analysis was planned and completed once ongoing pregnancy data were available for 50% of the total enrollment goal...
February 2018: Fertility and Sterility
Nardin Aslih, Adrian Ellenbogen, Tal Shavit, Medeia Michaeli, Devora Yakobi, Einat Shalom-Paz
Our study aimed to determine whether mid-luteal serum P concentrations can serve as a predictive factor for in vitro fertilization (IVF) outcomes and whether increasing P dosage for patients with low levels at mid-luteal phase may improve pregnancy rates. It was a prospective, randomized controlled study. A total of 146 patients undergoing IVF treatment were prospectively enrolled and received routine luteal phase support (LPS) regimen of Endometrin® (progesterone) 200 mg/day. Serum P levels were measured 7 days after embryo transfer (ET)...
March 9, 2017: Gynecological Endocrinology
Angeline N Beltsos, Mark D Sanchez, Kevin J Doody, Mark R Bush, Alice D Domar, Michael G Collins
BACKGROUND: Administration of exogenous progesterone for luteal phase support has become a standard of practice. Intramuscular (IM) injections of progesterone in oil (PIO) and vaginal administration of progesterone are the primary routes of administration. This report describes the administration preferences expressed by women with infertility that were given progesterone vaginal insert (PVI) or progesterone in oil injections (PIO) for luteal phase support during fresh IVF cycles. METHODS: A questionnaire to assess the tolerability, convenience, and ease of administration of PVI and PIO given for luteal phase support was completed by infertile women diagnosed with PCOS and planning to undergo IVF...
November 11, 2014: Reproductive Health
Valerie L Baker, Christopher A Jones, Kevin Doody, Russell Foulk, Bill Yee, G David Adamson, Barbara Cometti, Gary DeVane, Gary Hubert, Silvia Trevisan, Fred Hoehler, Clarence Jones, Michael Soules
STUDY QUESTION: Is the ongoing pregnancy rate with a new aqueous formulation of subcutaneous progesterone (Prolutex(®)) non-inferior to vaginal progesterone (Endometrin(®)) when used for luteal phase support of in vitro fertilization? SUMMARY ANSWER: In the per-protocol (PP) population, the ongoing pregnancy rates per oocyte retrieval at 12 weeks of gestation were comparable between Prolutex and Endometrin (41.6 versus 44.4%), with a difference between groups of -2...
October 10, 2014: Human Reproduction
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
Eve C Feinberg, Angeline N Beltsos, Elitsa Nicolaou, Edward L Marut, Meike L Uhler
OBJECTIVE: To compare clinical pregnancy rate (PR) and live birth rate (LBR) between Endometrin monotherapy versus Endometrin and P in oil combination therapy in assisted reproductive technology (ART) cycles. DESIGN: Retrospective analysis. SETTING: Large private practice. PATIENT(S): Patients undergoing autologous fresh IVF cycles, autologous frozen ET cycles, and fresh oocyte donor cycles were included for analysis...
January 2013: Fertility and Sterility
Jerome H Check
Supplementation of progesterone in the luteal phase and continuance of progesterone therapy during the first trimester has been found in several studies to have benefits in promoting fertility, preventing miscarriages and even preventing pre-term labor. Though it can be administered orally, intramuscularly or even sublingually, a very effective route with fewer side effects can be achieved by an intravaginal route. The first vaginal preparations were not made commercially but were compounded by pharmacies. This had the disadvantage of lack of control by the Food and Drug Administration (FDA) ensuring efficacy of the preparations...
August 2009: Therapeutics and Clinical Risk Management
Emily J Blake, Paul M Norris, Sally Faith Dorfman, James Longstreth, Vladimir I Yankov
OBJECTIVE: To determine pharmacokinetic profiles of two times a day and three times a day dosage regimens of Endometrin, a micronized progesterone vaginal insert for luteal support in assisted reproductive technology, compared with a gel. DESIGN: A single-center, randomized, open-label, single-day, and multiple-day (5 days) parallel design pharmacokinetic study. SETTING: University clinical research unit. PATIENT(S): Three groups of six healthy subjects, ages 18 to 40 years...
September 2010: Fertility and Sterility
Naveed Khan, Kevin S Richter, Tasha L Newsome, Emily J Blake, Vladimir I Yankov
OBJECTIVE: To evaluate vaginal compared to intramuscular (IM) progesterone supplementation for luteal phase support after in vitro fertilization and embryo transfer (IVF-ET). DESIGN: Retrospective matched-samples comparative study. SETTING: Private infertility center. PATIENTS(S): Two hundred forty patients undergoing IVF-ET. INTERVENTION(S): Patients received either vaginal progesterone supplementation in the form of Endometrin 100 mg twice a day (n = 12), Endometrin 100 mg three times a day (n = 11), or Crinone 8% gel 90 mg every day (n = 17), or 50 mg every day IM progesterone in oil (n = 200)...
June 2009: Fertility and Sterility
Kevin J Doody, Vicki L Schnell, Russell A Foulk, Charles E Miller, Bradford A Kolb, Emily J Blake, Vladimir I Yankov
OBJECTIVE: To assess the efficacy and safety of a vaginal progesterone (P(4)) insert (Endometrin) for luteal support for assisted reproductive technology (ART). DESIGN: Multicenter, randomized, open-label (assessor-blinded) phase III clinical trial. SETTING: Twenty-five U.S. ART centers. PATIENT(S): A total of 1,211 ART patients randomized to three groups: Endometrin 100 mg twice daily (n = 404), Endometrin 100 mg three times daily (n = 404), and P(4) 90 mg 8% gel daily (n = 403)...
April 2009: Fertility and Sterility
Ernest Hung Yu Ng, Carina Chi Wai Chan, Oi Shan Tang, Pak Chung Ho
OBJECTIVE: This study compared side effects and patient convenience of vaginal progesterone suppositories (Cyclogest) and vaginal progesterone tablets (Endometrin) used for luteal phase support in in vitro fertilization/embryo transfer (IVF/ET) cycles using pituitary downregulation. STUDY DESIGN: One hundred and thirty-two infertile patients were randomized on the day of ET by a computer-generated randomization list in sealed envelopes to receive either Cyclogest 400mg or Endometrin 100mg twice daily for 14 days...
April 2007: European Journal of Obstetrics, Gynecology, and Reproductive Biology
No abstract text is available yet for this article.
1951: Annales de la Société Royale des Sciences Médicales et Naturelles de Bruxelles
A Lewin, G Pisov, R Turgeman, M Fatum, Y Shufaro, A Simon, N Laufer, A Revel, B Reubinoff, A Safran
There are various successful protocols for artificial endometrial preparation, comprising induction of endometrial proliferation with estrogens and secretory transformation with progestins. The aim of this prospective randomized study was to evaluate a simplified approach for endometrial preparation, comparing two constant doses of oral estradiol combined with a novel low-dose vaginal natural progesterone preparation (100 mg Endometrin tablets). Twenty-nine patients were enrolled in the study and divided randomly into two groups...
April 2002: Gynecological Endocrinology
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