Clinical trial NCT01633528: The Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy
Official title: To Evaluate the Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy in Frozen Embryo Transfer Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: low dose aspirin endometrial thickness pregnancy rate ICSI IVF embryo transfer
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2012-07-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has been reported that low-dose aspirin and Heparin would lead to an increased Pregnancy rate in patients undergoing IVF-ET. Low-dose aspirin may improve uterine and ovarian perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness as well, which could result in better implantation and pregnancy rates after IVF or ICSI treatment. This study assesses potential effects of low-dose aspirin (100 mg daily) on pregnancy rate following frozen embryo transfer.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with "long or antagonist" protocol
* Women who did not achieve a pregnancy following a fresh embryo transfer or women whom their embryos had not been transferred due to OHSS
* The women who had frozen embryos available for another transfer no contraindications for aspirin

Exclusion Criteria:

* The patients with history of recurrent abortion

Primary outcomes:
measure: Pregnancy rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Implantation rate
timeFrame: 8 weeks
measure: Miscarriage rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Endocrinology and Female Infertility Department
name: Tahereh Madani, MD
role: STUDY_DIRECTOR
affiliation: Reproductive Imaging Department
name: Firoozeh Ahmadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Embryology Department
name: Poopak Eftekhary, PhD
role: PRINCIPAL_INVESTIGATOR
References: