Does progesterone support in luteal phase deficiency help subfertile couples achieve a pregnancy?

Phase 3

Recruiting

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

• Registration Number: ACTRN12612000166875
• 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
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 180

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

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 (16 days after peak mucus sign or 15 days of sustained temperature shift in this population charting their menstrual cycle) for up to 8 months]

Secondary Outcome Measures

Name	Time	Method
Time to conception[Diagnosis of pregnancy for up to 8 months];DASS 21 scores - screening for depression, anxiety and stress[Diagnosis of pregnancy for up to 8 months OR at completion of trial (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 (8 months) if not pregnant];Live birth rate[Completion of index pregnancy];Miscarriage rate[Completion of index pregnancy];Gestation and weight at birth[Completion of index pregnancy];Congenital anomalies[Completion of index pregnancy];Neonatal morbidity composite - nursery admission for any reason, and to include intraventricular haemorrhage, respiratory distress syndrome, necrotising enterocolitis[Up to 4 weeks post delivery];Maternal morbidity composite - to include antepartum haemorrhage, gestational hypertension, pre-eclampsia, gestational diabetes, venothromboembolic events, postnatal depression[Conception to 4 weeks post delivery]