NCT01064219

Brief Summary

Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation. It has been demonstrated that regulatory T cells expand during pregnancy. hCG was found to be secreted by the embryo immediately after fertilization and has chemoattractant properties to Treg cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 5, 2013

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

February 5, 2010

Last Update Submit

November 2, 2013

Conditions

Keywords

hCGTreg cellsimplantationpinopodesendometrium

Outcome Measures

Primary Outcomes (1)

  • the presence of Treg cells and pinopodes in the endometrium

    4 weeks

Secondary Outcomes (1)

  • pregnancy rate

    4 weeks

Study Arms (1)

intrauterine hCG

EXPERIMENTAL

intrauterine injection of 100 hCG followed by endometrial biopsy

Drug: human chorionic gonadotrophin

Interventions

intrauterine injection of 100 IU hCG followed by endometrial biopsy .

Also known as: choriomon
intrauterine hCG

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male factor infertility
  • Ovulatory factor infertility
  • Unexplained infertility
  • Female age less than 39

You may not qualify if:

  • Azoospermia
  • Tubal factor infertility
  • Pelvic endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Links

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Ragaa Mansour, MD,PhD

    The Egyptian IVF-ET Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, the Egyptian IVF-ET Center

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 8, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 5, 2013

Record last verified: 2010-12

Locations