NCT07351747

Brief Summary

This study aims to determine the efficacy of laser acupoint therapy on treating fallopian tube obstruction.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

April 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 10, 2026

Last Update Submit

January 10, 2026

Conditions

LaserAcupointsFallopian Tube Obstruction

Outcome Measures

Primary Outcomes (1)

  • Tubal patency

    Hysterosalpingography (HSG) will be used to assess tubal patency. It is a radiographic technique where a contrast material is injected into the uterine cavity, and X-ray images are taken to evaluate the shape of the uterus and the status of the fallopian tubes. HSG will be applied before the treatment and again three months post-treatment to evaluate changes in tubal patency HSG will be applied before treatment and after 3 months post-treatment.

    3 months post-treatment

Secondary Outcomes (2)

  • Anti-Müllerian Hormone (AMH) Test

    3 months post-treatment

  • Quantitative Pregnancy Test

    3 months post-treatment

Study Arms (2)

Study Group (Group A)

EXPERIMENTAL

Patients will receive laser acupoints therapy addition to standard care.

Other: Laser acupoints therapy + Standard care

Control Group (Group B)

PLACEBO COMPARATOR

Patients will receive placebo laser acupoints therapy in addition to standard care.

Other: Standard care

Interventions

Laser acupoints therapy + Standard careOTHER

Patients will receive laser acupoints therapy addition to standard care.

Study Group (Group A)
Standard careOTHER

Patients will receive placebo laser acupoints therapy in addition to standard care.

Control Group (Group B)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen diagnosed with fallopian tube obstruction.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 20-35 years - nulliparous.
  • Women diagnosed with fallopian tube obstruction.
  • Body mass index less than 30 kg/m2.
  • Consent to participate in the study.
  • General good health with no major co-existing medical conditions that could interfere with the treatment or outcomes.
  • No prior fertility treatments \[e.g., In vitro fertilization (IVF), intrauterine insemination (IUI)\] within the last 6 months.
  • Ability to attend all scheduled sessions and follow-up assessments.

You may not qualify if:

  • Currently pregnant or breastfeeding.
  • History of pelvic surgery within the past year.
  • Presence of severe systemic diseases such as active cancer or severe cardiovascular diseases.
  • History of allergic reactions or adverse responses to acupuncture or laser therapies.
  • Currently undergoing hormonal therapy or use of hormonal contraceptives.
  • Current or recent history of genital tract infections, including sexually transmitted. infections, which could affect the reproductive system.
  • Presence of significant uterine anomalies diagnosed through imaging that could impact fertility.
  • Polycystic Ovary Syndrome (PCOS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University (Faculty of Physical Therapy)

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Adnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Hadeer E Shalaby, MBBCH

CONTACT

00201554488336hadeershaalaaby@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physical Therapist, Kafrelsheikh General Hospital, Kafrelsheikh, Egypt.

Study Record Dates

First Submitted

January 10, 2026

First Posted

January 20, 2026

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)