RecruitingPhase 3ACTRN12612000174886

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?


Sponsor

Dr Luke McLindon

Enrollment

126 participants

Start Date

Feb 10, 2012

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding progesterone (to support the second half of the cycle) and amoxycillin (an antibiotic that may help cervical mucus) to clomiphene citrate treatment increases the chances of pregnancy in women who have not been ovulating regularly. All women in the study will also learn the Sympto-Thermal fertility awareness method. Researchers hope this combination will help more women achieve a successful pregnancy. You may be eligible if: - You are a woman aged 18 or older - You have been diagnosed with anovulation (not ovulating) and are currently ovulating on clomiphene citrate treatment - You have been trying to get pregnant for 12 months without success, OR have had 3 or more miscarriages You may NOT be eligible if: - Your infertility is due to blocked tubes (confirmed by testing) - Your infertility is due to a male factor (abnormal sperm analysis) - You are exclusively breastfeeding - You are currently using contraception - You are currently pregnant - You are currently taking other fertility medications or supplements - You are allergic to penicillin Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 cycl

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)

Australia

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