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

Sponsor

Benha University (Other)

Overall Status

Completed

CT.gov ID

NCT03770026

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female, Associated With Anovulation	Drug: clomiphene citrate Drug: Saline cervical flushing Biological: Intrauterine Autologous platelet-rich plasma	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clomiphene citrate only 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.	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. Other Names: Clomiphene Drug: 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. Other Names: Saline
Experimental: Platelet-rich plasma plus Clomiphene 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.	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. Other Names: Clomiphene 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. Other Names: Platelet-rich plasma

Arm

Intervention/Treatment

Active Comparator: Clomiphene citrate only

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.

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.

Other Names:

Clomiphene

Drug: 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.

Other Names:

Saline

Experimental: Platelet-rich plasma plus Clomiphene

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.

Drug: clomiphene citrate

Other Names:

Clomiphene

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.

Other Names:

Platelet-rich plasma

Outcome Measures

Primary Outcome Measures

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

Power Doppler estimation of endometrial and sub-endometrial vascularity [1 day]
Endometrial and sub-endometrial vascularity signals will be evaluated using the power Doppler.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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