Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility
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 infert...
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doaj-045d66ddf8804cda9b405801c873a71f2020-11-25T03:20:35ZengJCDR Research and Publications Private LimitedJournal of Clinical and Diagnostic Research2249-782X0973-709X2016-01-01101QC08QC1010.7860/JCDR/2016/17058.7106Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained InfertilityJaideep Malhotra0Korukonda Krishnaprasad1Director, Global Rainbow Healthcare, Rainbow Hospitals, Agra, India.Consultant Gynaecologist, Chembur, Mumbai, India.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.https://jcdr.net/articles/PDF/7106/17058_CE[Ra]_F(Sh)_PF1(BMAK)_PFA(AK)_PF2(PAG).pdfdydrogesteroneluteal phase supportoral nmp sr |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jaideep Malhotra Korukonda Krishnaprasad |
spellingShingle |
Jaideep Malhotra Korukonda Krishnaprasad Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility Journal of Clinical and Diagnostic Research dydrogesterone luteal phase support oral nmp sr |
author_facet |
Jaideep Malhotra Korukonda Krishnaprasad |
author_sort |
Jaideep Malhotra |
title |
Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility |
title_short |
Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility |
title_full |
Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility |
title_fullStr |
Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility |
title_full_unstemmed |
Open-label, Prospective, Investigator Initiated Study to Assess the Clinical Role of Oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility |
title_sort |
open-label, prospective, investigator initiated study to assess the clinical role of oral natural or synthetic progesterone during stimulated iui cycles for unexplained infertility |
publisher |
JCDR Research and Publications Private Limited |
series |
Journal of Clinical and Diagnostic Research |
issn |
2249-782X 0973-709X |
publishDate |
2016-01-01 |
description |
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. |
topic |
dydrogesterone luteal phase support oral nmp sr |
url |
https://jcdr.net/articles/PDF/7106/17058_CE[Ra]_F(Sh)_PF1(BMAK)_PFA(AK)_PF2(PAG).pdf |
work_keys_str_mv |
AT jaideepmalhotra openlabelprospectiveinvestigatorinitiatedstudytoassesstheclinicalroleoforalnaturalorsyntheticprogesteroneduringstimulatediuicyclesforunexplainedinfertility AT korukondakrishnaprasad openlabelprospectiveinvestigatorinitiatedstudytoassesstheclinicalroleoforalnaturalorsyntheticprogesteroneduringstimulatediuicyclesforunexplainedinfertility |
_version_ |
1724617865830596608 |