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?
In anovulatory women receiving clomiphene citrate does progesterone given as luteal phase support and amoxycillin given as a cervical mucus enhancer compared to placebo increase the likelihood of pregnancy?
Dr Luke McLindon
126 participants
Feb 10, 2012
Interventional
Conditions
Summary
This project aims to assess the effectiveness of progesterone (as luteal phase support) and amoxycillin (as a cervical mucus enhancer) for pregnancy achievement, in previously anovulatory women currently ovulating on clomiphene citrate (+/- metformin). All women will be instructed in a fertility awareness-based method (the Sympto-Thermal Method). It is hypothesised that: 1. Progesterone given as luteal phase support increases the likelihood of pregnancy in subfertile women receiving clomiphene citrate for anovulation. 2. Amoxycillin (as cervical mucus enhancer) plus progesterone (as luteal phase support) increases the likelihood of pregnancy in subfertile women receiving clomiphene citrate for anovulation.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria7
- Subfertility is due to tubal causes (defined as abnormal hysterosalpingography and/or laparoscopy & dye insufflation, and/or hysterosalpingography with contrast by sonography (HyCoSy))
- Subfertility is due to male factor (absence of a normal /effective seminal fluid analysis within last six months (WHO criteria))
- Women who are exclusively breastfeeding
- Currently using contraception
- Currently pregnant
- Currently using any prescribed fertility-enhancing medications or supplements, including Vitex agnus
- Women who have a penicillin allergy
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Interventions
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
Locations(1)
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ACTRN12612000174886