Duration of luteal support with progesterone pessaries to improve the success rates in assisted conceptio

Not Applicable

Completed

• Conditions: Infertilty; Pregnancy and Childbirth; Female infertility

• Registration Number: ISRCTN05696887
• Lead Sponsor: iverpool Women's NHS Foundation Trust (UK)

Brief Summary

2012 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/22834768 protocol

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-26
• Study Completion: 2012-05-26
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 460

Inclusion Criteria

All patients undergoing IVF will be considered for the DOLS Trial
1. Biochemical pregnancy confirmed by urinary pregnancy test. If positive then they will be eligible to enter the trial
2. Progesterone treatment (2 weeks) completed up to the day of the pregnancy test
3. Patients treated at Hewitt centre only
4. Only those patients who have been treated with the long stimulation protocol
5. Only patients having used Menopur for controlled ovarian stimulation

Exclusion Criteria

1. All women who are undergoing frozen embryo transfer
2. Any women not willing to take part will be excluded
3. All diabetic, epileptic and hypertensive patients on treatment
4. Poorly controlled asthmatics having had more than one hospital admission in the last year
5. Patients with renal and cardiac dysfunction (Under the care of nephrologist and cardiologist respectively)
6. Breast Cancer patients
7. Severe liver impairment/jaundice
8. Previous history of thromboembolism
9. Transport centre patients, ie egg collection at Chester or Leighton
10. Patients previously recruited to the DOLS Trial
11. Patients who have not had a long cycle of IVF

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The proportion of all randomised women that continue successfully to a viable pregnancy (at least one fetus with FHR >100 beats minute) on transabdominal / transvaginal ultrasound at 10 weeks post embryo transfer / 12 weeks gestation (i.e. at the end of 8 weeks supplementary trial treatment).<br><br> The following clinical estimates are available. The success rate at the biochemical testing stage is approximately 32.5%. Currently without further progesterone supplementation, 80% of these women will carry on successfully with a viable pregnancy (25.8% of clinical pregnancy rate) whilst 20% of these women will miscarry. We anticipate that an increase of 10% from the biochemical to the clinical pregnancy rate would be clinically important and therefore justify an additional 8 weeks of supplementation with progesterone, in other words, a reduction of 10% in the miscarriage rate.<br>