Clinical trial NCT03770026: Autologous Platelet-rich Plasma for Clomiphene Citrate-induced Thin Endometrium
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility, Female, Associated With Anovulation
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Endometrial thickness
timeFrame: 1 day
Secondary outcomes:
measure: Power Doppler estimation of endometrial and sub-endometrial vascularity
timeFrame: 1 day
measure: Clinical pregnancy rate
timeFrame: At the end of a 28-day menstrual cycle.
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha Faculty Hospital
state: Alkalubia
Study officials:
affiliation: Banha Faculty of Medicine, Banha Univerisity
name: Ahmed Walid A Morad
role: PRINCIPAL_INVESTIGATOR
References: