Infertility, Female, Associated With Anovulation
Conditions
Brief summary
This is a prospective self-controlled clinical study. Women with clomiphene Citrate failure with thin endometrium less than 7 millimeters for at least 3 cycles will be selected (N = 30). Patients will receive 2 ovarian stimulation cycles with Clomiphene citrate (CC) 100 mg/ day for 5 days from cycle day 3. A control cycle (CC only cycle) woman will continue on CC alone plus cervical irrigation of cervix with 1 ml of 0.9% normal saline at cycle day 8 and 10 to assure patient-blinded method. The study group, the same will be done plus the intrauterine infusion of Autologous platelet-rich plasma (PRP) in 8th and 10th days of the cycle. In both groups, the endometrial thickness and Power Doppler evaluation of their endometrial and sub-endometrial blood flow will be measured on the day of Human Chorionic Gonadotropin (HCG) administration.
Detailed description
This is a pilot prospective self-controlled clinical trial. Women with Clomiphene Citrate failure with documented thin endometrium less than 7 millimeters for at least 3 stimulation cycles will be chosen (N = 30). Patients will experience 2 ovarian stimulation cycles with Clomiphene citrate (CC) in a dose of 100 mg/ day for 5 days starting from cycle day 3. A control cycle (CC only cycle) woman will continue on Clomiphene Citrate alone plus cervical irrigation of cervix with 1 ml of 0.9% normal saline at cycle day 8 and 10 to confirm patient-blinded process. The study group, the same will be done in addition to the intrauterine infusion of with Autologous platelet-rich plasma (PRP) in 8th and 10th days of the cycle. In both groups, the endometrial thickness and Power Doppler evaluation of their endometrial and sub-endometrial blood flow will be measured on the day of HCG administration.
Interventions
DRUGclomiphene citrate
Clomiphene citrate-only arm: Patients will receive Clomiphene citrate induction (in a dose of 100 mg/day starting from day 3 of the cycle for 5 days). Sonographic assessment of endometrial thickness together with Power Doppler evaluation endometrial and sub-endometrial blood flow a will be done in the Day of HCG injection.
DRUGSaline cervical flushing
Cervical irrigation with 1 ml of 0.9% normal saline will be done at cycle day 8 and 10 to convince patient-blinded procedure.
BIOLOGICALIntrauterine Autologous platelet-rich plasma
Under complete aseptic cares and ultrasound supervision, Autologous platelet-rich plasma (0.5 - 1 ml) was immediately injected into the uterine cavity using an intrauterine insemination catheter in the cycle days 8 and 10. The Autologous platelet-rich plasma is prepared in collaboration with the Department of Clinical Pathology, Faculty of Medicine, Benha University.
Sponsors
Benha University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women with clomiphene citrate failure (defined as at least previous 3 ovulatory cycles with clomiphene citrate, with no pregnancy), * persistently thin endometrium (less than 7 millimeters in at least 3 cycles). * normal baseline Follicle Stimulating Hormone, Luteinizing Hormone, and free testosterone levels, patent tubes by hysterosalpingography, and satisfactory male semen analysis
Exclusion criteria
* previous ovarian surgery; * endocrine disorders ; * pelvic pathologies; * chronic hepatic, cardiovascular, or renal disease; * other factors of infertility and * use of gonadotropins or hormonal contraception through the latest 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial thickness | 1 day | Transvaginal sonographic estimation of maximal distance traversing endometrial- myometrial interphase on each endometrial stripe in a -midsagittal plane in the uterine fundus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | At the end of a 28-day menstrual cycle. | Recognizing pregnancy through positive urinary HCG test plus sonographic detection of cardiac pulsations |
| Power Doppler estimation of endometrial and sub-endometrial vascularity | 1 day | Endometrial and sub-endometrial vascularity signals will be evaluated using the power Doppler. |
Countries
Egypt
Outcome results
None listed