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

NCT03770026 | Completed Phase 2

• 1 other identifier: 181210
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female, Associated With Anovulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Power Doppler estimation of endometrial and sub-endometrial vascularity

  1 day

• Clinical pregnancy rate

  At the end of a 28-day menstrual cycle.

Study Arms (2)

Clomiphene citrate only

ACTIVE COMPARATOR

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; Drug: Saline cervical flushing

Platelet-rich plasma plus Clomiphene

EXPERIMENTAL

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; Biological: Intrauterine Autologous platelet-rich plasma

Interventions

clomiphene citrate DRUG

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.

Also known as: Clomiphene

Clomiphene citrate only; Platelet-rich plasma plus Clomiphene

Saline cervical flushing DRUG

Cervical irrigation with 1 ml of 0.9% normal saline will be done at cycle day 8 and 10 to convince patient-blinded procedure.

Also known as: Saline

Clomiphene citrate only

Intrauterine Autologous platelet-rich plasma BIOLOGICAL

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.

Also known as: Platelet-rich plasma

Platelet-rich plasma plus Clomiphene

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha Faculty Hospital

Banhā, Alkalubia, 13511, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ahmed Walid A Morad

  Banha Faculty of Medicine, Banha Univerisity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obestetrics and Gynecology

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

EG (1)