Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

NCT03579550 | Unknown

• 1 other identifier: KA17/151
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The correlation between dysmorphic uterus and infertility still remains enigmatic. We aim to evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained infertile women with dysmorphic uterus with comparing a group of unexplained infertile women performing 6 months spontaneous cycles plus 3 cycles controlled ovarian hyperstimulation and intrauterine insemination by randomized trial.

Conditions

Hysteroscopy; Pregnancy Rate; Abortion; Ectopic Pregnancy; Intrauterine Insemination

Keywords

dysmorphic uterus, metroplasty, hysteroscopy

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate (CPR)

  Intrauterine gestational sac with viable fetal heart rate

  9 months

Secondary Outcomes (2)

• abortion

  10 weeks

• ectopic pregnancy rate

  10 weeks

Study Arms (2)

Intervention arm: Hysterocopy group

ACTIVE COMPARATOR

Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group

Procedure: office hysteroscopic metroplasty intervention arm

Spontaneous cycles plus COH/IUI

NO INTERVENTION

Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)

Interventions

office hysteroscopic metroplasty intervention arm PROCEDURE

One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI

Also known as: spontaneous coitus plus COH/IUI

Intervention arm: Hysterocopy group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: women with dysmorphic uterus
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Unexplained infertile couples with;
• Dysmorpic uterus in hysterosalpingography
• Normal spermiogram
• \. Bilateral patent tubes in hysterosalpingography 3. Normal ovarian reserve (AMH \>1.5 ng/dl and/or total bilateral antral follicle count \>8)

You may not qualify if:

• Women with history of pelvic surgery including endometriosis and/or tubal surgery
• women with endometrioma which was visualised/suspected on transvaginal ultrasonography
• Women with anovulation
• Women with diminished ovarian reserve (AMH \< 1.5 ng/dl and/or total bilateral antral follicle count \<8)
• Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia)
• Women with alive children
• Obese women (BMI\>30 kg/m2)

Sponsors & Collaborators

• Bulent Haydardedeoglu: lead

Study Sites (1)

Bulent Haydardedeoglu

Adana, 01120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Bulent Haydardedeoglu, Assoc.Prof.

  Baskent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Prof. M.D.

Model Details: prospective randomised trial

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 6, 2018
• Study Start: June 8, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 30, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

TU (1)