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Clinical Trials/ACTRN12612000166875
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.

Registry
who.int
Start Date
February 6, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Dr Luke McLindon

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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