Infertility, Ovarian Hyperstimulation, Pregnancy, Primary Infertility Unspecified
Conditions
Keywords
ICSI, IVF, hysteroscopy, Supervision, In-vitro Fertilization
Brief summary
The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.
Detailed description
Proper history, examination and investigations are carried out to diagnose causes of infertility. Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. Controlled ovarian hyper stimulation-embryo transfer (COH-ET) using the standard long protocol of induction used in Ain Shams University Maternity Hospitals ART (assisted reproductive techniques) unit. Biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.
Interventions
PROCEDUREHysteroscopy
Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle. All OH (office hysteroscopy) procedures will be performed with a vaginoscopic approach without utilizing a speculum and applying traction to the cervix with a tenaculum. Antibiotic prophylaxis: None OH will be cancelled until after treatment of vaginal infection.
DEVICEHysteroscope
The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 4-mm diameter diagnostic sheath with an atraumatic tip (Karl Storz Endoscopy). Illumination: High intensity cold light source and fiberoptic cable Distention medium: solution of 0.9% normal saline with pressure at 100-120 mmHg
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol. * No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase. * Patients with unexplained primary infertility.
Exclusion criteria
* Patients undergoing IVF using other protocols of induction. * Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase. * Other causes of infertility rather than unexplained factor. * Unexplained poor responders during the pending ICSI cycle. * Patients with abnormal findings at hysteroscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Pregnancy | 2-6 weeks | Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks) |
Contacts
Primary ContactAmr A. Abdulreheem, MBBCh
Backup ContactMoustafa F Gomaa, PhD
Outcome results
None listed