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?

Phase 3

Recruiting

• Conditions: Subfertility; Anovulation; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12612000174886
• Lead Sponsor: Dr Luke McLindon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive pregnancy test.<br><br>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).[Pregnancy test is to be performed in the clinical setting of a missed period on any cycle within the trial period for up to 8 months. (usually defined as 16 days after peak mucus sign or 15 days of sustained temperature shift in this population charting their menstrual cycle).]