NCT04536389

Brief Summary

The aim of our study is to investigate the pregnancy rates in women with normal uterine cavity ,with and without cervical abnormalities.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 28, 2020

Last Update Submit

August 28, 2020

Conditions

Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    clinical pregnancy rate will be described

    7thweek of prgnancy for cardiac pulsations

Secondary Outcomes (3)

  • chemical pregnancy rate

    4 weeks

  • Abortion rate

    up to 28 weeks

  • preterm labour

    9 months

Study Arms (2)

group A

women with normal uterine cavity and normal cervix by office hysteroscopy.

Procedure: Office Hysteroscopy

group B

women with normal uterine cavity with hysteroscopically detected cervical abnormality.

Procedure: Office Hysteroscopy

Interventions

Office HysteroscopyPROCEDURE

The hysteroscope with its light source and flowing fluid was gently introduced into the vagina allowing for gradual distention. Once this was accomplished, the anatomy was followed with delicate movements. The hysteroscope was advanced under vision to the level of the ectocervix, and guided into the endocervical canal. Once the endocervical canal was completely explored, the endoscope was advanced across the internal cervical os to allow evaluation of the panoramic view of the uterine cavity. hysteroscopic correction of any detected lesion will be scheduled to the endoscopic operative list or the patient will receive the appropriate medical treatment.

group Agroup B

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All infertile women will be assessed in IVF\&ICSI unite of Women Health hospital,Assiut university and will be recruted according to the inclusion criteria.

You may qualify if:

  • \. Women between 18 and 38 years old. 2. An indication for IVF/ICSI. 3. Women with primary or secondary infertility. 4. Women with BMI between 20 \& 35.

You may not qualify if:

  • \. Refusal to join the study. 2. Untreated tubal hydrosalpinges. 3. Poor responders as assessed by AFC 4 or less, AMH O.8 ng/dl (nice 2013).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Women Health Hospital, Assiut University, Egypt

Asyut, 71111, Egypt

RECRUITING

Related Publications (4)

  • Pardo J, Yogev Y, Ben-Haroush A, Peled Y, Kaplan B, Hod M. Cervical length evaluation by transvaginal sonography in nongravid women with a history of preterm delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):464-6. doi: 10.1002/uog.116.

    PMID: 12768558RESULT

  • Mazouni C, Bretelle F, Blanc K, Heckenroth H, Haddad O, Agostini A, Cravello L, Blanc B, Gamerre M. Transvaginal sonographic evaluation of cervix length after cervical conization. J Ultrasound Med. 2005 Nov;24(11):1483-6. doi: 10.7863/jum.2005.24.11.1483.

    PMID: 16239649RESULT

  • Robert AL, Nicolas F, Lavoue V, Henno S, Mesbah H, Poree P, Leveque J. [Ultrasonographic evaluation of the uterine cervix length remaining after LOOP-excision]. J Gynecol Obstet Biol Reprod (Paris). 2014 Apr;43(4):288-93. doi: 10.1016/j.jgyn.2013.03.014. Epub 2013 Apr 25. French.

    PMID: 23623518RESULT

  • Herfs M, Vargas SO, Yamamoto Y, Howitt BE, Nucci MR, Hornick JL, McKeon FD, Xian W, Crum CP. A novel blueprint for 'top down' differentiation defines the cervical squamocolumnar junction during development, reproductive life, and neoplasia. J Pathol. 2013 Feb;229(3):460-8. doi: 10.1002/path.4110.

    PMID: 23007879RESULT

Central Study Contacts

Ahmed M. Kamel, MSc&MBBH

CONTACT

01003627020ahmedmomen414@yahoo.com

Ibrahim I. Mohammed, MD&MSC

CONTACT

01001027715ibraheem_hendy@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 2, 2020

Study Start

October 1, 2018

Primary Completion

September 30, 2020

Study Completion

October 30, 2020

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations

EG(1)