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

Benha University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility, Female, Associated With Anovulation

Treatments: Biological: Intrauterine Autologous platelet-rich plasma; Drug: Saline cervical flushing; Drug: clomiphene citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03770026

181210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No 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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Clomiphene citrate only

Active Comparator group

Description:

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.

Treatment:

Drug: clomiphene citrate

Drug: Saline cervical flushing

Platelet-rich plasma plus Clomiphene

Experimental group

Description:

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.

Treatment:

Drug: clomiphene citrate

Biological: Intrauterine Autologous platelet-rich plasma