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NCT03770026

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

Completed Phase 2, PHASE3 Last updated 29 April 2020
What this trial tests

Phase 2, PHASE3 trial testing clomiphene citrate in Infertility, Female, Associated With Anovulation in 30 participants. Completed in 1 January 2020.

Timeline
1 January 2018
Primary endpoint
1 January 2019
1 January 2020

Quick facts

Lead sponsorBenha University
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment30
Start date1 January 2018
Primary completion1 January 2019
Estimated completion1 January 2020
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Benha University

Who can join

Adults 18 to 35, female only, with Infertility, Female, Associated With Anovulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Therapeutic roles of platelet-rich plasma to restore female reproductive and endocrine dysfunction.
    Wang X, Li J, Lu W, Gao F, et al · · 2024 · cited 8× · PMID 38654928 · DOI 10.3389/fendo.2024.1374382

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