NCT02355925

Brief Summary

The present study is designed as a pilot study with 150 patients in each group. Data collection form will be filled by the researcher who does not know the type of intervention in each group. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 20 for windows

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Typical duration for phase_3

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

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 28, 2018

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

January 27, 2015

Last Update Submit

December 26, 2018

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Evaluation the rate of clinical pregnancy 4-6 weeks after embryo transfer

    4 weeks

Secondary Outcomes (4)

  • Ongoing pregnancy

    20 weeks

  • early miscarriage rate

    12 weeks

  • Chemical pregnancy rate

    2 weeks

  • Late miscarriage rate20 weeks

    20 weeks

Study Arms (3)

uhCG

EXPERIMENTAL

The patients who receive Intrauterine injection of 500 IU of uhCG (0.5ml) before embryo transfer

Drug: intrauterine injection of uhCG

Placebo

PLACEBO COMPARATOR

The patients who underwent Intrauterine injection of placebo (normal saline 0.5 ml) before embryo transfer

Drug: Placebo

control

OTHER

the embryonic transfer is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups.

Other: control

Interventions

intrauterine injection of uhCGDRUG

40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA, Switzerland) is injected intrauterine, approximately 7 minutes before embryo transfer.

uhCG
PlaceboDRUG

only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.

Placebo
controlOTHER

the embryonic transfer is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups.

control

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with history of one fresh embryo transfer failure
  • Patients with Primary infertility
  • Patients with at least one embryo with excellent quality

You may not qualify if:

  • \. Female age over 40 years old 2- Severe male factor (Azoospermia) 3- Endometriosis diagnosis and the presence of hydrosalpinges 4- Uterine factor ( polyps, myoma and previous myomectomy, …) 5- Patients with polycystic ovarian syndrome diagnosis 6- Cases with pre-implantation genetic diagnosis (PGD)indication 7- Cases with difficult embryo transfer or use of Tenaculum 8- Patients with repeated implantation failures and repeated miscarriages. 9- Female smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • Hafezi M, Madani T, Arabipoor A, Zolfaghari Z, Sadeghi M, Ramezanali F. The effect of intrauterine human chorionic gonadotropin flushing on live birth rate after vitrified-warmed embryo transfer in programmed cycles: a randomized clinical trial. Arch Gynecol Obstet. 2018 Jun;297(6):1571-1576. doi: 10.1007/s00404-018-4752-2. Epub 2018 Apr 6.

    PMID: 29626233DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Maryam Hafezi, MD

    Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

    STUDY DIRECTOR

  • Tahereh Madani, MD

    Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

    STUDY DIRECTOR

  • Arezoo Arabipour, MSC

    Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

February 4, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 28, 2018

Record last verified: 2016-05

Locations

IR(1)