Does progesterone given as luteal phase support and amoxycillin as cervical mucus enhancer increase the likelihood of pregnancy in subfertile women receiving clomiphene citrate for anovulation?

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: Arm 1: Periovulatory placebo (one orally three times daily) days 11‐16 AND progesterone pessaries (400 mg vaginally at night) during each luteal phase (used for 10 consecutive nights) for up to 8 cycles OR Arm 2: Periovulatory amoxycillin (500mg orally three times daily) days 11‐16 AND progesterone pessaries (400 mg vaginally at night) during each luteal phase (used for 10 consecutive nights) for up to 8 cycles All participants will be instructed in the Sympto‐Thermal Method. All participants will be administered Clomiphene citrate orally (+/‐ metformin orally) at a dose necessary to induce ovulation CONDITION: Anovulation Subfertility PRIMARY OUTCOME: Positive pregnancy test. ; ; This is defined as HCG > 25 mIU/L. This test is either a quantitative serum level or a qualitative urine point of care test (which becomes positive at a level of 25 mIU/L). SECONDARY OUTCOME: Acceptability of intervention ‐ by completion of an acceptability survey tool Congenital anomalies Cost effectiveness ‐ looking at time, resources, medications, clinical setting costs DASS 21 Scores ‐ screening for depression, anxiety and stress Gestation and weight at birth Live birth rate Maternal morbidity composite ‐ to include antepartum haemorrhage, gestational hypertension, pre‐eclampsia, gestational diabetes, venothrombo‐embolism, postnatal depression Miscarriage rate Neonatal morbidity composite ‐ nursery admission (for any reason and including intraventricular haemorrhage, necrotising enterocolitis, respiratory distress syndrome) Time to conception INCLUSION CRITERIA: 1. Anovulation (based on prolonged and hormonally quiescent 'cycles') AND A. Failing to achieve a pregnancy after 12 months of unprotected random intercourse OR B. Failing to achieve an ongoing pregnancy (greater than 20 weeks) after 12 months of unprotected random intercourse OR C. A history of 3 or more miscarriages
Epistemonikos ID: 7bb8420222d0d76c454465fe49671f3537919e7c
First added on: Aug 25, 2024