ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03173404
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

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

Condition or disease Intervention/treatment Phase
Sterility Procedure: Hysteroscopy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Group I
Patients underwent hysteroscopy examination before IVF cycle.
Procedure: Hysteroscopy
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.

No Intervention: Group II
Patients underwent direct IVF cycle without previous hysteroscopy.



Primary Outcome Measures :
  1. Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment [ Time Frame: 12 months ]
    Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment comparing both groups.


Secondary Outcome Measures :
  1. Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies. [ Time Frame: 12 months ]
    Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies in the rate of pregnancy and livebirth.

  2. Rate of hysteroscopy tolerance [ Time Frame: 1 month. ]
    The tolerance of the procedure was evaluate in the patients randomized to the group I of the study.

  3. Hysteroscopy complication rate. [ Time Frame: 2 months ]
    We evaluate the complication of the hysteroscopy during and after the procedure. Includes blooding, infections, uterine perforation, etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients included in the study must be female with uterus.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173404


Locations
Spain
La Paz University Hospital
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03173404     History of Changes
Other Study ID Numbers: 3913
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female