NCT02330705

Brief Summary

Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

December 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

4.5 years

First QC Date

December 31, 2014

Last Update Submit

January 24, 2019

Conditions

Infertility

Keywords

Intrauterine inseminationIUIHCG

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after IUI) divided by the number of IUI cycles

    4-6 weeks after IUI

Study Arms (3)

Group A

ACTIVE COMPARATOR

IUI at time of HCG

Drug: HCG

Group B

ACTIVE COMPARATOR

IUI 12 hours after HCG

Drug: HCG

Group C

ACTIVE COMPARATOR

IUI 34-36 hours after HCG

Drug: HCG

Interventions

HCGDRUG

Women will be given HCG before IUI

Also known as: Pregnyl
Group AGroup BGroup C

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mild male factor infertility or unexplained infertility.

You may not qualify if:

  • Advanced male factor infertility.
  • Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.
  • Endometriosis.
  • Tubal disease.
  • Uterine abnormalities or myoma.
  • Previous uterine surgery.
  • Metabolic or hormonal abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fertility care unit (FCU) in Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

Private fertility care centers

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

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

  • Mohamed I Eid, Dr

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed I Eid, Dr

CONTACT

+201225401274dr_moh_eid@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 31, 2014

First Posted

January 5, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

EG(2)