Autologous Platelet-rich Plasma for Clomiphene Citrate-induced Thin Endometrium

Infertility, Female, Associated With Anovulation Clinical Trial

Official title:

Intrauterine Infusion of Autologous Platelet-rich Plasma to Prevent a Thin Endometrium in Infertile Women Undergoing Clomiphene Citrate Therapy: a Pilot Prospective Self-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770026
• Other study ID #: 181210
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anovulation
• Infertility
• Infertility, Female
• Infertility, Female, Associated With Anovulation

Intervention

Drug:
• clomiphene 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.
• Saline 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.

Biological:
• Intrauterine 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.

Locations

Country	Name	City	State
Egypt	Banha Faculty Hospital	Banha	Alkalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial thickness	Transvaginal sonographic estimation of maximal distance traversing endometrial- myometrial interphase on each endometrial stripe in a -midsagittal plane in the uterine fundus.	1 day
Secondary	Power Doppler estimation of endometrial and sub-endometrial vascularity	Endometrial and sub-endometrial vascularity signals will be evaluated using the power Doppler.	1 day
Secondary	Clinical pregnancy rate	Recognizing pregnancy through positive urinary HCG test plus sonographic detection of cardiac pulsations	At the end of a 28-day menstrual cycle.