NCT02668965

Brief Summary

The purpose of this study is to determine whether intrauterine hCG can improve the implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

January 27, 2016

Last Update Submit

January 28, 2016

Conditions

Infertility

Keywords

Clinical pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats

    2 weeks after positive serum beta-hCG

Secondary Outcomes (2)

  • Chemical pregnancy rate

    2 weeks after embryo transfer

  • Implantation rate

    2 weeks after positive serum beta-hCG

Study Arms (2)

control

NO INTERVENTION

intrauterine infusion with standard embryo culture media 10 microliters before embryo transfer

intrauterine hCG

EXPERIMENTAL

intrauterine infusion with hCG (500 IU) 10 microliters before embryo transfer

Procedure: Intrauterine hCG (pregnyl)

Interventions

Intrauterine hCG (pregnyl)PROCEDURE
intrauterine hCG

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • infertile women aged 18-43 years
  • indicated or willing for IVF/ICSI treatment or endometrial preparation for embryo transfer

You may not qualify if:

  • Azoospermic male partner
  • Failure to retrieve oocyte after controlled ovarian hyperstimulation
  • No embryo retrieved for transfer
  • Endometrial preparation failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infertility unit, Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

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

Central Study Contacts

savinee boonsuk, M.D.

CONTACT

+66818706643noomnim_mu@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Miss

Study Record Dates

First Submitted

January 27, 2016

First Posted

January 29, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

January 29, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

Locations

TH(1)