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Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles

Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03680690
Enrollment
244
Registered
2018-09-21
Start date
2018-10-01
Completion date
2020-02-28
Last updated
2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracytoplasmic Sperm Injection

Brief summary

The aim of the current study is to investigate the pregnancy rate in women with normal uterine cavity and those detected or corrected uterine cavitary lesions, assessed by hysteroscopy in ICSI cycles.

Detailed description

Intrauterine pathology has been reported in up to 25% of infertile women having IVF treatment and in as many as 50% of women with recurrent implantation failure, leading to suggestions that correction of such pathology could improve treatment outcome. Hysteroscopy allows visual assessment of the cervical canal and uterine cavity and provides the opportunity to operate in the same setting. Routine outpatient hysteroscopy before starting IVF has been postulated to diagnose and treat abnormalities of the cervix and uterine cavity and hence improve IVF outcome. A systematic review of published studies suggested that outpatient hysteroscopy in the menstrual cycle preceding an IVF treatment cycle could significantly increase the clinical pregnancy rate in women who had previously had recurrent implantation failure, even when no hysteroscopic abnormality was detected. However, the result of the TROPHY study - published in the Lancet in 2016 concluded that Outpatient hysteroscopy before IVF in women with a normal ultrasound of the uterine cavity and a history of unsuccessful IVF treatment cycles does not improve the livebirth rate and they recommended that further research into the effectiveness of surgical correction of specific uterine cavity abnormalities before IVF is warranted. An MD thesis done in our department on the evaluation of the endometrial cavity in infertile patients and prior to IVF recommended that there is an urgent need to RCT to emphasize the benefit of removal of the detected intrauterine lesions before proceeding to IVF.

Interventions

PROCEDUREhysteroscopy

office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes

Inclusion criteria

* Women between 18 and 38 years old. * An indication for IVF/ICSI. * Normal 2D transvaginal U/S assessment of the uterine cavity, or abnormal cavity detected by 2D ,3D and HSG. * Women with primary or secondary infertility. * Women with BMI between 20 & 35.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rate7th week of pregnancy for cardiac pulsations.Clinical pregnancy rate Will be evaluated

Secondary

MeasureTime frameDescription
Chemical pregnancy rate Chemical pregnancy rate4 weeksChemical pregnancy rate Chemical pregnancy rate
Implantation rate6 weeksImplantation rate for assessment of implanted embryos
Abortion rateup to 28 weekAbortion rate will be observed
Preterm labour rate9 monthsDelivary before term 37 weeks of pregnancy

Contacts

Primary ContactAhmed Kamel, MSc/Mbbh
ahmedmomen414@yahoo.com00201003627020
Backup ContactAhmed Youssef, MD/Mssc/Mbbh
ahmedalaa11828@yahoo.com01006184921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026