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

NCT01563822 | Completed Phase 1 DMC

• 1 other identifier: 132012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intra-cytoplasmic Sperm Injection Outcome

Keywords

Follicular Fluid; uterine cavity; Implantation rates; ICSI

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  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.

  17 days

Secondary Outcomes (1)

• Implantation rate

  17 days

Study Arms (2)

follicular fluid group

EXPERIMENTAL

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

control group

NO INTERVENTION

Control group is the group in which flushing of the uterine cavity with follicular fluid after ovum pick-up is not done.

Interventions

Follicular fluid BIOLOGICAL

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

follicular fluid group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Presence of Endometriosis.
• Presence of Hydrosalpinx.
• Presence of vaginal infection.
• Presence of galactorrhea.
• Presence of hormonal disorders.
• Severe male factor infertility:
• Sperm Count \< one million. Marked malformation
• history of recurrent abortion.

Sponsors & Collaborators

• Nawara Mohamed Hashish: lead

Study Sites (1)

Kasr El-Aini hospital

Cairo, Egypt

Location

Study Officials

• Nawara Mohamed Hashish, MD

  Department of Obstetrics and Gynecology,Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 27, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

EG (1)