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

Not Applicable

• Conditions: nexplained subfertility; Unexplained subfertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12612000164897
• Lead Sponsor: Dr Luke McLindon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-06
• Study Completion: 2012-11-06
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 17

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive pregnancy test. <br><br>This is defined as HCG > 25 mIU/L. This test is either a quantitative serum level or a qualitative urine point of care test (which becomes positive at a level of 25 mIU/L).[Pregnancy test is to be performed in the setting of a clinically missed period (for those charting this is 16 days after peak mucus sign or 15 days of sustained temperature shift) for up to 8 months]

Secondary Outcome Measures

Name	Time	Method
Time to conception[Diagnosis of pregnancy for up to 8 months];Live birth rate[Completion of index pregnancy];Miscarriage rate[Completion of index pregnancy];Gestation and weight at birth[Completion of index pregnancy];Accuracy of method in determining expected date of confinement[Completion of index pregnancy];DASS 21 scores - screening tool for depression, anxiety and stress[Diagnosis of pregnancy for up to 8 months OR at completion of trial at 8 months if not pregnant];Acceptability of intervention - by way of an acceptability survey tool[Diagnosis of pregnancy for up to 8 months OR at completion of trial at 8 months if not pregnant]