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?

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000174886

Acronym

Pregnancy Achieving Trial 3 (PATrial 3)

Enrollment

126

Registered

2012-02-08

Start date

2012-02-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 w

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Exclusion criteria

1. Subfertility is due to tubal causes (defined as abnormal hysterosalpingography and/or laparoscopy & dye insufflation, and/or hysterosalpingography with contrast by sonography (HyCoSy)) 2. Subfertility is due to male factor (absence of a normal /effective seminal fluid analysis within last six months (WHO criteria)) 3. Women who are exclusively breastfeeding 4. Currently using contraception 5. Currently pregnant 6. Currently using any prescribed fertility-enhancing medications or supplements, including Vitex agnus 7. Women who have a penicillin allergy

Outcome results