Does monitoring fertile times of the menstrual cycle help subfertile couples achieve a pregnancy?

In women with unexplained subfertility, does a fertility awareness-based charting method compared to generic fertility instruction increase the likelihood of pregnancy?

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000164897

Acronym

Pregnancy Achieving Trial – PATrial 1

Enrollment

Registered

2012-02-06

Start date

2011-08-16

Completion date

2012-11-06

Last updated

2022-01-31

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 will assess the effectiveness of a fertility awareness-based charting method in increasing the likelihood of pregnancy in a population with unexplained subfertility. It is hypothesised that the Sympto-Thermal Method increases the likelihood of pregnancy in the unexplained ovulating subfertile population.

Interventions

Instruction (presented as a face-to-face session for approximately 40 minutes) in the Sympto-Thermal charting Method lasting, documented on a temperature/mucus chart for up to 8 months. This will occur in addition to the instruction in fertility awareness (group session for 20 minutes) that both trial arms will receive.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Women with a normal hormonal profile in the luteal phase of the menstrual cycle AND A. Women failing to achieve a pregnancy after 12 months of unprotected random intercourse OR B. Women failing to achieve an ongoing pregnancy (greater than 20 weeks) after 12 months of unprotected random intercourse OR c. Women with 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 ever used a fertility awareness-based method

Outcome results