Does progesterone support in luteal phase deficiency help subfertile couples achieve a pregnancy?
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 McLindon
180 participants
Feb 7, 2012
Interventional
Conditions
Summary
This project aims to assess the effectiveness of progesterone as luteal phase support in unexplained subfertile women with a previously diagnosed luteal phase hormonal deficiency. All women will be instructed in a fertility awareness-based charting method (the Sympto-Thermal method). It is hypothesised that progesterone given as luteal phase support increases the likelihood of pregnancy in unexplained subfertile women with a recognised luteal phase hormonal defect.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- Subfertility is due to tubal causes (defined as abnormal hysterosalpingography and/or laparoscopy & dye insufflation, and/or hysterosalpingography with contrast by sonography (HyCoSy))
- Subfertility is due to male factor (absence of a normal /effective seminal fluid analysis within last six months (WHO criteria))
- Women who are exclusively breastfeeding
- Currently using contraception
- Currently pregnant
- Currently using any prescribed fertility-enhancing medications or supplements, including Vitex agnus
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Interventions
Progesterone pessaries (400 mg vaginally nightly) during each luteal phase (used for 10 consecutive nights), for up to 8 months/cycles. Formal instruction in the Sympto-Thermal Method is routinely provided.
Locations(1)
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ACTRN12612000166875