Misoprostol Before Hysteroscopy in Infertile Cases

NCT ID: NCT02409407

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-05-31

Brief Summary

The role of hysteroscopy in infertility investigation is to detect possible intrauterine changes that could interfere with implantation or growth or both of the conceptus, with the invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention. It is currently acknowledged as the 'gold standard' investigation of the intrauterine abnormalities.

Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force needed for dilation, thereby potentially reducing the probability of procedural complication such as uterine perforation, cervical laceration, failure to dilate, and creation of a false track that can occur during cervical entry.

Misoprostol is a prostaglandin El analogue, that can be administered either orally or vaginally, that can cause cervical ripening by inducing collagenolytic activity and synthesis of proteoglycans.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Oral Misoprostol

oral misoprostol ( prostaglandins E1 analogue) will be administered at a dose of 600 µg (200 µg every 8 hours), starting 24 hours before office hysteroscopy.

Group Type: EXPERIMENTAL

Misoprostol , Prostaglandins E1 analogue

Intervention Type: DRUG

Vaginal Misoprostol

vaginal misoprostol ( prostaglandins E1 analogue)will be administered at a dose of 400 µg (200 µg 12 hours apart, starting 24 hours before office hysteroscopy)

Group Type: EXPERIMENTAL

Misoprostol , Prostaglandins E1 analogue

Intervention Type: DRUG

Placebo

oral placebo (one pill every 8 hours) will be administered starting 24 hours before the office hysteroscopy.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Misoprostol , Prostaglandins E1 analogue

Intervention Type: DRUG

Other Intervention Names

Misotac

Eligibility Criteria

Inclusion Criteria

• Female patients aged from 20 to 40 years old.
• They are complaining with primary or secondary infertility.
• They undergo investigations including husband semen analysis, hormonal assay, U/S, Hystrosalpingography.

Exclusion Criteria

• Known sensitivity to misoprostol.
• Any systemic disease contraindicating the use of prostaglandins (cardiovascular disease, hypertension, renal failure, etc).
• Concomitant neurologic disease that could affect the correct evaluation of pain.
• Pregnancy.
• Any contraindication to hysteroscopy such as Pelvic inflammatory disease (PID).
• Heavy uterine bleeding.
• Any uterine abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yomna Ali Bayoumi

Lecturer of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yomna A Bayoumi, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr El Aini Hospital

Locations

Kasr el Ainy hospital

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yomna A Bayoumi, MD

Role: CONTACT

dryomnabayoumi@gmail.com

01066812955 ext. 002

Facility Contacts

Yomna A Bayoumi, MD

Role: primary

dryomnabayoumi@gmail.com

01066812955 ext. 002

Other Identifiers

MS20150303

Identifier Type: -

Identifier Source: org_study_id