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?

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000166875

Acronym

Pregnancy Achieving Trial 2 (PATrial 2)

Enrollment

180

Registered

2012-02-06

Start date

2012-02-07

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 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.

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.

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. 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

Outcome results