The Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: Asprin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Asprin
With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.
|
Drug: Asprin
100 mg
|
|
Placebo Comparator: placebo
With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo
|
Drug: placebo
100mg
|
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| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
- The patients with history of recurrent abortion
Contacts and Locations| Contact: Nasser Aghdami, MD/PhD | (+98)22172330 | nasser.aghdami@royaninstitute.org |
| Contact: Leila Arab, MD | (+98)22339951 | leila.arab@yahoo.com |
| Iran, Islamic Republic of | |
| Royan Institute | Recruiting |
| Tehran, Iran, Islamic Republic of | |
| Contact: Nasser Aghdami, MD,PhD (+98)22172330 nasser.aghdami@riyaninstitute.org | |
| Contact: Leila Arab, MD (+98)22339951 leila.aran@yahoo.com | |
| Principal Investigator: Nadia Jahangiri, MSC | |
| Sub-Investigator: Akram Bahmanabadi, BSC | |
| Sub-Investigator: Zohreh Rashidi, BSC | |
| Sub-Investigator: Narges Bagheri lankarani, PhD | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Royan Institute |
| ClinicalTrials.gov Identifier: | NCT01633528 History of Changes |
| Other Study ID Numbers: | Royan-Emb-014 |
| Study First Received: | May 14, 2012 |
| Last Updated: | July 1, 2012 |
| Health Authority: | Iran: Ethics Committee Iran: Ministry of Health |
Keywords provided by Royan Institute:
|
low dose aspirin endometrial thickness pregnancy rate ICSI IVF embryo transfer |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013