Does Flushing the Uterine Cavity With Follicular Fluid After Ovum Pick-up Improve Implantation Rates in ICSI Cycles?
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|ClinicalTrials.gov Identifier: NCT01563822|
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : October 10, 2012
Traditionally during ovum pick-up in ICSI, we aspirate the follicles for oocyte retrieval but unfortunately we don't make use of the follicular fluid (FF) and we discard it in spite of the fact that this does not happen in nature. The fallopian tube picks-up the FF with the oocyte during ovulation. As this fluid contains stem cell factor and C-Kit receptor responsible for implantation and IGF responsible for endometrial growth and TGF that improves implantation. That's why flushing the endometrial cavity with FF after ovum pick-up might improve endometrial receptivity and implantation rates; the limiting step in ICSI.
Patients and Methods:
100 patients attending kasr El-Aini IVF center preparing for ICSI cycles are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid surrounding mature oocytes through an IUI catheter is done after ovum pick-up While in the control group, no flushing of the endometrial cavity with FF is done. The implantation rates and pregnancy rates in both groups will be assessed.
|Condition or disease||Intervention/treatment||Phase|
|Intra-cytoplasmic Sperm Injection Outcome||Biological: Follicular fluid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of the Effect of Flushing the Uterine Cavity With Follicular Fluid After Ovum Pick-up on Implantation Rates in ICSI Cycles|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: follicular fluid group
Follicular fluid group is the group in which flushing of the uterine cavity with follicular fluid after ovum pick-up is done.
Biological: Follicular fluid
The intervention is flushing the uterine cavity with 2 ml of clear follicular fluid surrounding mature oocytes after ovum pick-up through an IUI catheter
No Intervention: control group
Control group is the group in which flushing of the uterine cavity with follicular fluid after ovum pick-up is not done.
- pregnancy rate [ Time Frame: 17 days ]The main outcome is the pregnancy rate in ICSI cycles after flushing the uterine cavity with follicular fluid after ovum pick-up in the study group and comparing it with the control group.
- Implantation rate [ Time Frame: 17 days ]The secondary outcome is the implantation rate in ICSI cycles after flushing the uterine cavity with follicular fluid after ovum pick-up in the study group and comparing it with the control group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563822
|Kasr El-Aini hospital|
|Principal Investigator:||Nawara Mohamed Hashish, MD||Department of Obstetrics and Gynecology,Cairo University|