ACTRN12612000166875
Recruiting
Phase 3
In women with unexplained subfertility and luteal phase deficiency, does luteal phase support with progesterone while using a fertility awareness-based charting method when compared to fertility awareness-based charting alone increase the likelihood of pregnancy?
Dr Luke McLindon0 sites180 target enrollmentFebruary 6, 2012
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- nexplained subfertility
- Sponsor
- Dr Luke McLindon
- Enrollment
- 180
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Luteal phase hormonal defect (based on oestradiol and progesterone serum levels drawn on days 5, 7 and 9 post\-ovulation) 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
Outcomes
Primary Outcomes
Not specified
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