Literature DB >> 26894126

Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility.

Jaideep Malhotra1, Korukonda Krishnaprasad2.   

Abstract

BACKGROUND: Unexplained infertility remains as one of the important subtype of infertility that follows expectant management with Intrauterine Insemination (IUI) in most cases. AIM: To evaluate the clinical role of progesterone supplement as luteal phase support for women with unexplained infertility following stimulation protocol with Clomiphene Citrate (CC)/Human Menopausal Gonadotropin (HMG).
MATERIALS AND METHODS: An investigator initiated study to survey the success rate for first cycle of IUI following stimulation protocol with CC/HMG & luteal phase support with oral natural or synthetic progesterone was conducted. 120 patient records between observation period of Jan to May '14 were retrieved especially for subjects undergoing IUI procedure for Unexplained infertility. Patients with baseline Serum (Sr). progesterone records who received Oral Natural Micronized Progesterone Sustained Release (Oral NMP SR) (N=45) or Dydrogesterone (n=33) following CC/HMG induction protocol and human Chorionic Gonadotropin(HCG) Inj., were further analysed following Luteal Phase Support(LPS) with oral natural or synthetic progesterone.
RESULTS: Baseline demographics showed 78 patients with mean age, weight and cycle duration of 29.5 yrs, 57.3 kg & 28.6 days respectively. Progesterone was supplemented as Oral NMP SR 200/300 mg OD or Dydrogesterone 10 mg bid in 22, 23 and 33 patients respectively. In all cases ovulation was triggered with HCG inj., followed by IUI within the next 48 hours while baseline sr. progesterone levels were being assessed. Medicines and Healthcare Products Regulatory Agency (MHRA) UK recommended therapeutic compliance to suggest sr. progesterone levels of ≥14ng/ml were recorded as Mid-luteal levels in all of these patients. This therapeutic compliance was noted in 82.2% & 78.8% of the patients treated with oral NMP SR or Dydrogesterone respectively. Pregnancy was observed amongst 5 and 10 patients treated with oral NMP SR and Dydrogesterone respectively at the end of 'First' IUI cycle. Both the groups were well tolerated with drowsiness documented in three cases for Oral NMP SR.
CONCLUSION: Clinical supplementation with ONMPSR suggests therapeutic compliance and alternative strategy to conventional formulations while offering dosing convenience with minimal side effects.

Entities:  

Keywords:  Dydrogesterone; Luteal phase support; Oral NMP SR

Year:  2016        PMID: 26894126      PMCID: PMC4740654          DOI: 10.7860/JCDR/2016/17058.7106

Source DB:  PubMed          Journal:  J Clin Diagn Res        ISSN: 0973-709X


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  8 in total
  2 in total

Review 1.  Luteal phase support for women trying to conceive by intrauterine insemination or sexual intercourse.

Authors:  Lingling Salang; Danielle M Teixeira; Ivan Solà; Jen Sothornwit; Wellington P Martins; Magdalena Bofill Rodriguez; Pisake Lumbiganon
Journal:  Cochrane Database Syst Rev       Date:  2022-08-24

Review 2.  A review of conventional and sustained-release formulations of oral natural micronized progesterone in obstetric indications.

Authors:  Girija Narendrakumar Wagh; K M Kundavi Shankar; Sumitra Bachani
Journal:  Drugs Context       Date:  2021-10-13
  2 in total

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