NCT02825108

Brief Summary

The present study is designed as a pilot study with 50 patients in each group. Data collection form will be filled by the researcher who does not know the type of intervention in each group

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 Jan 2015

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

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
2.4 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

June 1, 2016

Enrollment Period

3.9 years

First QC Date

July 4, 2016

Last Update Submit

December 26, 2018

Conditions

Infertility

Keywords

human chorionic gonadotropin (hCG), implantation rate intrauterine hCG clinical pregnancy rate frozen embryo transfer cycles

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    Evaluation of Implantation rate 6 weeks after embryo transfer.

    6 weeks

Secondary Outcomes (3)

  • Pregnancy loss

    12 weeks

  • Early miscarriage rate

    12 weeks

  • Late miscarriage rate

    20 weeks

Study Arms (3)

experimental group

EXPERIMENTAL

The patients who receive 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.

Drug: Intra uterine injection of tissue culture medium containing HCG+ET

placebo group

PLACEBO COMPARATOR

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

Drug: Intra uterine injection of tissue culture medium +ET

control group

OTHER

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

Procedure: ET

Interventions

Intra uterine injection of tissue culture medium containing HCG+ETDRUG

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.

experimental group
Intra uterine injection of tissue culture medium +ETDRUG

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

placebo group
ETPROCEDURE

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

control group

Eligibility Criteria

Age19 Years - 39 Years
Sexfemale
Healthy VolunteersYes
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
  • Severe male factor (Azoospermia)
  • Endometriosis diagnosis and the presence of hydrosalpinges
  • Uterine factor ( polyps, myoma and previous myomectomy, …)
  • Patients with polycystic ovarian syndrome diagnosis
  • Cases with pre-implantation genetic diagnosis (PGD)indication
  • Cases with difficult embryo transfer or use of Tenaculum
  • Patients with repeated implantation failures and repeated miscarriages.
  • Female smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Tahere Madani, MD

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

    STUDY DIRECTOR

  • Maryam Hafezi, MD

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

    STUDY DIRECTOR

  • Arezoo Arabipour, M.S.c

    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

July 4, 2016

First Posted

July 7, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 28, 2018

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)