Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

Study Overview
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Brief Summary
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IVF/ICSI patients who had difficult mock embryo transfer on the day of ovum pick up. Will be randomly assigned into two groups; group A will receive 100mg indomethacin rectal suppository 1-2 hours before ET and group B will not receive indomethacin

Official Title
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Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

Conditions
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Difficult Embryo Transfer

Intervention / Treatment
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* Drug: Indomethacin 100Mg Suppository
* Procedure: IVF/ICSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile patients undergoing IVF cycle with difficult mock embryo transfer Early follicular FSH level ≤10 IU/L. Tubal, male infertility and unexplained causes of fertility will be recruited. Fresh ET. Exclusion Criteria: Repeated IVF failure. Past history of allergy to NSAID, bronchial asthma , peptic ulcer or inflammatory bowel disease. Easy mock embryo transfer.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Indomethacin)<br>All patient had long stimulation protocol and IVF/ICSI. After mock embryo transfer women with any degree of difficulty will receive Indomethacin 100Mg Suppository 1-2 hours before embryo transfer. | Drug: Indomethacin 100Mg Suppository<br>* Indomethacin 100Mg Suppository will be given 1 to 2 hours before embryo transfer in cases with difficult mock embryo transfer in the active comparator group.<br>* Other names: Indomethacin;Procedure: IVF/ICSI<br>* patients received induction with the long agonist stimulation protocol. Followed by ovum pickup and embryo transfer. Only those with difficult mock embryo transfer will be recruited in this study.<br>|
| Placebo Comparator: Group B (Control)<br>All patient had long stimulation protocol and IVF/ICSI. After mock embryo transfer women with any degree of difficulty will not receive any medications before embryo transfer. | Procedure: IVF/ICSI<br>* patients received induction with the long agonist stimulation protocol. Followed by ovum pickup and embryo transfer. Only those with difficult mock embryo transfer will be recruited in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | the number of total gestational sacs divided by the total number of embryos transferred. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Presence of fetal pulsations after 2 weeks from the positive pregnancy test. | 6 weeks | 
| Ongoing pregnancy rate | Pregnancies continuing beyond 12 weeks | 12 weeks |