NCT03173404

Brief Summary

This is a prospective randomized open-label trial. Women scheduled for their first or second in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration 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

July 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

May 30, 2017

Last Update Submit

May 30, 2017

Conditions

Sterility

Outcome Measures

Primary Outcomes (1)

  • Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment

    Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment comparing both groups.

    12 months

Secondary Outcomes (3)

  • Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies.

    12 months

  • Rate of hysteroscopy tolerance

    1 month.

  • Hysteroscopy complication rate.

    2 months

Study Arms (2)

Group I

EXPERIMENTAL

Patients underwent hysteroscopy examination before IVF cycle.

Procedure: Hysteroscopy

Group II

NO INTERVENTION

Patients underwent direct IVF cycle without previous hysteroscopy.

Interventions

HysteroscopyPROCEDURE

The hysteroscopy is the visualization of the cervical canal and uterine cavity with a camera. Patients randomized to group I underwent hysteroscopy prior to the IVF cycle.

Group I

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients included in the study must be female with uterus.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with infertility / primary infertility.
  • Women who are about to start an IVF/ICSI cycle with their own eggs.
  • Age greater than or equal to 18 years and less than or equal to 40 years.
  • Women in whom a multiple follicular development will be developed with a short protocol with antagonists or long with agonists, and starting dose of gonadotropins according to clinical criteria.
  • Women with uterine ultrasound without endometrial pathology

You may not qualify if:

  • Ovarian reserve: Antimullerian hormone \<0.5 ng / dl or Count of antral follicles \<5 between both ovaries.
  • Myomatous uterus: presence of\> 2 myomas\> 4cm or that deform uterine cavity.
  • Uterine malformations.
  • Body mass index (BMI) \<18 or\> 30.
  • Polycystic ovarian syndrome: according to European Society of Human Reproduction and Embryology (ESRHE)/Rotterdam 2003 criteria.
  • Moderate-severe endometriosis.
  • Background or presence of pelvic inflammatory disease.
  • Hydrosalpinx not excised or occluded.
  • Hyperprolactinemia, defined as prolactin levels greater than 50 ng / ml.
  • Diagnostic history of endometrial hyperplasia.
  • Severe male factor: severe oligoasthenoteratozoospermia with a sperm cell count (REM) \<100,000 spermatozoa / ml.
  • Impossibility to apply the treatments provided by the study in the terms established by the protocol.
  • Contraindication for the use of any of the treatments provided in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized open-label clinical trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I): 31 patients underwent hysteroscopy examination before IVF cycle. The second group (group II): 37 patients underwent direct cycle without previous hysteroscopy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

July 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 1, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)