Office Hysteroscopy in Women Using Progesterone-only Contraception (POC)

NCT04368104 | Completed

• 1 other identifier: Darwish test and POC
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanisms of action of progesterone-only contraception (POC) include endometrial and Fallopian tubal changes without any scientific documentation. We succeeded to document proper assessment of the proximal part of the Fallopian tubes and test anatomic tubal patency as well (Darwishscope test) via hysteroscopy. This study will test endometrial pattern and Fallopian tubal status in women using progesterone-only contraception (POC) utilizing office hysteroscopy.

Conditions

Fallopian Tube Peristalsis and Patency; Endometrial Pattern

Keywords

hysteroscopy; tubal patency; bubble suction test; tubal peristalsis; minipills; endometrium

Outcome Measures

Primary Outcomes (1)

• office hysteroscopic endometrial and Fallopian tubal Darwishscope test in women using progesterone-only contraception (POC) versus non users of any hormones..

  case control

  1 month

Study Arms (2)

Group A

women using any form of minipills

Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)

Group B

women subjected to office hysteroscopy for different indications but not using any form of hormones or systemic or local hormonal contraception.

Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)

Interventions

Darwish test (office hysteroscopic bubble suction and tubal peristalsis) DIAGNOSTIC_TEST

Testing Darwish test (office hysteroscopic bubble suction test and proximal tubal peristalsis) in women using minipills versus other cases not using hormones..

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women using any form of progesterone-only contraception (POC) including minipills (Desogestrel 75 µg, or Norethisterone 350 µg), MPA, Merina or Implanon asigned as group A and women subjected to office hysteroscopy for other indications (group B).

You may qualify if:

• women using progesterone-only contraception (POC)
• women planned for office hysteroscopy for other indication.

You may not qualify if:

• A suspected pregnancy.
• heavy vaginal bleeding.
• active pelvic inflammatory disease (PID).
• severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease
• Other medical contraindications to pregnancy

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: August 3, 2021
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)