Autologous Platelet-rich Plasma for Clomiphene Citrate-induced Thin Endometrium
Condition: Infertility, Female, Associated With Anovulation
MeSH terms: Infertility; Infertility, Female; Anovulation
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): clomiphene citrate; Saline cervical flushing; Intrauterine Autologous platelet-rich plasma
Intervention type(s): Drug; Drug; Biological
Intervention description(s): 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.; Cervical irrigation with 1 ml of 0.9% normal saline will be done at cycle day 8 and 10 to convince patient-blinded procedure.; 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.
Other intervention name(s): Clomiphene; Saline; Platelet-rich plasma
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment