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Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection

Primary Purpose

Sterility

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Hysteroscopy

About this trial

This is an interventional diagnostic trial for Sterility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

La Paz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group I

Group II

Arm Description

Patients underwent hysteroscopy examination before IVF cycle.

Patients underwent direct IVF cycle without previous hysteroscopy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies in the rate of pregnancy and livebirth.

Rate of hysteroscopy tolerance

The tolerance of the procedure was evaluate in the patients randomized to the group I of the study.

Hysteroscopy complication rate.

We evaluate the complication of the hysteroscopy during and after the procedure. Includes blooding, infections, uterine perforation, etc.

Full Information

NCT ID

NCT03173404

First Posted

May 30, 2017

Last Updated

May 30, 2017

Sponsor

Instituto de Investigación Hospital Universitario La Paz

1. Study Identification

Unique Protocol Identification Number

NCT03173404

Brief Title

Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection

Official Title

Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

July 1, 2014 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed Description

This is a prospective randomized open-label 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 while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy. Then IVF cycle was performed with habitual protocol. Beta Corionic Gonatropic hormone (BhCG) test two weeks after embryo transfer was done. If test was positive, patients were followed up for detection pregnancy by transvaginal ultrasound two weeks later. Another transvaginal ultrasound at 12 weeks of gestation was done to confirm ongoing pregnancy. Biochemical pregnancy, implantation, on-going pregnancy and livebirth rates were compared in both groups. Miscarriage, complications rate and hysteroscopy tolerability were also analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sterility

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Description

Patients underwent hysteroscopy examination before IVF cycle.

Arm Title

Group II

Arm Type

No Intervention

Arm Description

Patients underwent direct IVF cycle without previous hysteroscopy.

Intervention Type

Procedure

Intervention Name(s)

Hysteroscopy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies in the rate of pregnancy and livebirth.

Time Frame

12 months

Title

Rate of hysteroscopy tolerance

Description

The tolerance of the procedure was evaluate in the patients randomized to the group I of the study.

Time Frame

1 month.

Title

Hysteroscopy complication rate.

Description

We evaluate the complication of the hysteroscopy during and after the procedure. Includes blooding, infections, uterine perforation, etc.

Time Frame

2 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Patients included in the study must be female with uterus.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Facility Information:

Facility Name

La Paz University Hospital

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection

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