The Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||To Evaluate the Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy in Frozen Embryo Transfer Cycles|
- Pregnancy rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.
- Implantation rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Evaluation the implantation rate after emberyo transfer in women who use low dose of aspirin
- Miscarriage rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluation the miscariage rate after emberyo transfer in women who use asprin.
|Study Start Date:||May 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.
Placebo Comparator: placebo
With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo
In the present randomized double-blind prospective study, the patients will be randomly assigned to the study and control groups. With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin and the control group will be given placebo. When endometrial thickness will be found between 8-14 mm, therapy with progesterone (100 mg IM daily) will be started and embryo transfer will be performed 48 to 72 hours later. Doppler ultrasonography also is done to calculate Resistive Index (RI) and Pulsatility Index (PI), the day after progesterone administration.
βHCG will be assessed 14 days after ET. If a pregnancy will be achieved, the patients in study and control groups will be instructed to continue the aspirin or placebo through 5 weeks and if the pregnancy test result will be negative, the treatment with aspirin or placebo will be stopped. The patients will be followed until 20 weeks of gestation and the results of treatment cycle will be compared in two groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633528
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan institute|
|Study Director:||Tahereh Madani, MD||Endocrinology and Female Infertility Department|
|Principal Investigator:||Firoozeh Ahmadi, MD||Reproductive Imaging Department|
|Principal Investigator:||Poopak Eftekhary, PhD||Embryology Department|