Autologous Platelet-rich Plasma for Clomiphene Citrate-induced Thin Endometrium
- Conditions
- Infertility, Female, Associated With Anovulation
- Interventions
- Drug: Saline cervical flushingBiological: Intrauterine Autologous platelet-rich plasma
- Registration Number
- NCT03770026
- Lead Sponsor
- Benha University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Clomiphene citrate only Saline cervical flushing Infertile women (30 women) with prior clomiphene citrate failure (ovulation was documented without conception), with thin endometrium (\<7mm) in at least 3 cycles. Saline cervical flushing will be done at cycle day 8 and 10 to convince patient-blinded procedure. Platelet-rich plasma plus Clomiphene Intrauterine Autologous platelet-rich plasma Women who did not conceive on the Clomiphene citrate-only cycle will receive Clomiphene citrate 100 mg/ day starting from the third day of the cycle. Intrauterine Autologous platelet-rich plasma will be done on the cycle days 8 and 10. Clomiphene citrate only clomiphene citrate Infertile women (30 women) with prior clomiphene citrate failure (ovulation was documented without conception), with thin endometrium (\<7mm) in at least 3 cycles. Saline cervical flushing will be done at cycle day 8 and 10 to convince patient-blinded procedure. Platelet-rich plasma plus Clomiphene clomiphene citrate Women who did not conceive on the Clomiphene citrate-only cycle will receive Clomiphene citrate 100 mg/ day starting from the third day of the cycle. Intrauterine Autologous platelet-rich plasma will be done on the cycle days 8 and 10.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Banha Faculty Hospital
🇪🇬Banha, Alkalubia, Egypt