NCT06165484

Brief Summary

Current in-vitro fertilization (IVF) consumers are enjoying better success rates than early seekers, but only about a quarter of IVF cycles result in a live birth and many patients remain infertile after multiple IVF attempts. Recurrent IVF failure is distressing to patients and challenging to clinicians. Despite interventions have been proposed to improve IVF outcome after couples of failed cycles, only a few of which are evidence based. Laparoscopy, as the gold standard for the evaluation of the pelvis, was used to be the routine procedure for many reproductive physicians. It provides information on endometriosis, tubal patency, and pelvic adhesions and a chance to fix these lesions concurrently.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

November 20, 2023

Last Update Submit

December 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improving the pregnancy outcome in patients with recurrent IVF failure.

    To assess if the diagnosis and treatment of pelvic or uterine pathologies with laparoscopy and hysteroscopy is of role in improving the pregnancy outcome (live birth rate and ongoing pregnancy rate) in patients with recurrent IVF failure .

    1.5 YEARS

Secondary Outcomes (1)

  • Abnormal laparoscopy findings and surgery-related complications

    1.5 YEARS

Study Arms (1)

patient with failed ivf cycle

EXPERIMENTAL
Procedure: laparoscopy and hysteroscopy

Interventions

laparoscopy and hysteroscopy for patient with failed IVF

patient with failed ivf cycle

Eligibility Criteria

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

You may qualify if:

  • \. The patients ages ranged from 20 to 40 years. 2. menstrual cycles with a duration of 24 to 38 days and no ovulatory dysfunction. 3. normal findings of pelvic ultrasonography and HSG assessment, without visible lesions that could cause implantation failure, for example: endometrial polyps, submucosal myomas, uterine septum and intrauterine adhesions.
  • \. hormonal values were within the normal range. 5. Semen analyses were normal according to the World Health Organization (WHO) 2010 criteria.
  • \. no previous surgical treatment for endometriosis; no previous oophorectomy or salpingectomy.
  • \. Patients included in the study had failed to conceive after at least one cycles of IVF-ET when indicated.

You may not qualify if:

  • \- 1. Couples with severe male factor infertility. 2. Premature ovarian failure. 3. Patients with a poor ovarian reserve and poor responders. 4. Contraindication to laparoscopy such as mechanical or large abdominal mass (\> 24 weeks gestation size).
  • \. Contraindication to hysteroscopy such as recent or active pelvic inflammatory disease and active uterine bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Interventions

LaparoscopyHysteroscopy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeDiagnostic Techniques, Obstetrical and GynecologicalObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 11, 2023

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion

November 1, 2025

Last Updated

December 27, 2023

Record last verified: 2023-12