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Does Flushing the Uterine Cavity With Follicular Fluid After Ovum Pick-up Improve Implantation Rates in ICSI Cycles?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nawara Mohamed Hashish, Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT01563822
First received: March 20, 2012
Last updated: October 6, 2012
Last verified: October 2012
History of Changes
  Purpose

Background:

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 Intervention Phase
Intra-cytoplasmic Sperm Injection Outcome
 Biological: Follicular fluid
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Kasr El Aini Hospital:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: 17 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 17 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Maternal age ranges from 20-38 years.
  2. Basal FSH < 10 mIU/ml.
  3. BMI < 35 kg/m2.
  4. Estradiol level > 1000 at the day of HCG administration.
  5. Estradiol level < 4000 at the day of HCG administration.

Exclusion Criteria:

  1. Presence of Endometriosis.
  2. Presence of Hydrosalpinx.
  3. Presence of vaginal infection.
  4. Presence of galactorrhea.
  5. Presence of hormonal disorders.

  6. Severe male factor infertility:

    Sperm Count < one million. Marked malformation

  7. history of recurrent abortion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563822

Locations
Egypt
Kasr El-Aini hospital
Cairo, Egypt
Sponsors and Collaborators
Nawara Mohamed Hashish
Investigators
Principal Investigator: Nawara Mohamed Hashish, MD Department of Obstetrics and Gynecology,Cairo University
  More Information

No publications provided

Responsible Party: Nawara Mohamed Hashish, Assistant professor of Obstetrics and Gynecology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT01563822     History of Changes
Other Study ID Numbers: 132012
Study First Received: March 20, 2012
Last Updated: October 6, 2012
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Kasr El Aini Hospital:
Follicular Fluid
uterine cavity
Implantation rates
ICSI

Additional relevant MeSH terms:
Flushing
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013