Physical Endometrial Manipulation and Its Effect on ICSI

NCT03345251 | Completed DMC

• 1 other identifier: Algazeerah
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .

Conditions

Infertility

Keywords

ICSI - physical - Manipulation - scratching

Outcome Measures

Primary Outcomes (1)

• The number of participants who achieved clinical pregnancy

  Describes how many participant will continue pregnancy after positive pregnancy test

  6 weeks after embryo transfer

Secondary Outcomes (1)

• The number of participants who achieved ongoing pregnancy and live birth

  9 months after embryo transfer

Study Arms (2)

manipulation of endometrium

EXPERIMENTAL

The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching

Device: Hydrotubation

no manipulation to endometrium in ICSI

PLACEBO COMPARATOR

This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group

Device: Hydrotubation

Interventions

Hydrotubation DEVICE

Also known as: Sonohysterography, Endometrial scratching

manipulation of endometrium; no manipulation to endometrium in ICSI

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile female age 20-35 years
• Previous Failed one ICSI trial
• normal basal hormonal profile \[FSH, LH\] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity
• patent tubes
• normal Husband semen analysis

You may not qualify if:

• Ovarian factor of infertility
• Tubal factor of infertility
• Endometrial factor of infertility
• Male factor of infertility

Sponsors & Collaborators

• Aljazeera Hospital: lead

Study Sites (1)

Algazeerah

Giza, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Mahmoud Alalfy, master

  Algazeerah hospital -Location (Giza -Egypt )

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mahmoud Alalfy

Model Details: 640 were enrolled but 608 were analyzed

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 17, 2017
• Study Start: January 3, 2017
• Primary Completion: December 25, 2017
• Study Completion: December 28, 2017
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)