N/A
N=120
Endometrial Injury for Unexplained Infertility
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT02863198 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Measurement of Uterine Artery Pulsatility Index — 2.40; 2.35 index — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- endometrial injury (Device)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Benha University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Uterine Artery Pulsatility Index |
2.40; 2.35 | <0.05 sig |
| PRIMARY Measurement of Uterine Artery Resistance Index |
0.86; 0.85 | <0.05 sig |
| PRIMARY Appearance of Sub Endometrial Blood Flow in All Patients |
33; 12 | <0.05 sig |
| PRIMARY Spiral Artery Pulsatility Indices in All Patients |
1.19; 1.01 | <0.05 sig |
| PRIMARY Spiral Artery Doppler Resistance Indices in All Patients |
0.62; 0.66 | <0.05 sig |
| SECONDARY Pregnancy Rate Between the Study and the Control Group |
11; 4 | <0.05 sig |
Summary
One hundred and twenty women with unexplained infertility were included in the study. Divided randomly into two groups:
Group I: (60 patients): (control group)
Group II (60 patients): (study group)
All the patients received (CC) and human menopausal gonadotropin. On day 5 of the cycle, Doppler examination was performed to all patients. Also on day 5, but only for group (II) patients, local endometrial injury was performed. Doppler studies was repeated, for all our patients, on the same day of prescribing human chorionic gonadotropin
Eligibility Criteria
Inclusion Criteria
- age Between 20 - 35 years
- Body mass index 18-29 kg/m2
- primary infertility for more than two years, and planning for IVF/intracytoplasmic sperm injection trial
- Normal ovulation confirmed by previous US
- Normal hormonal profile follicle stimulating hormone, luteinizing hormone, and prolactin, Antimullerian hormone (AMH) more than 1 ng/ml
- Normal hysterosalpingography
- Normal laparoscopic finding
- normal semen analysis, according to World Health Organization 2010
Exclusion Criteria
- Absence of inclusion criteria
- History of previous laparotomy
- Patients with history which may suggest endometriosis
- Associated chronic medical conditions e.g. cardiac disease, diabetes, renal disease… etc.
Data sourced from ClinicalTrials.gov (NCT02863198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.